TITLE 9. ENVIRONMENT

STATE AIR POLLUTION CONTROL BOARD

Final Regulation

Titles of Regulations: 9VAC5-80. Permits for Stationary Sources (amending 9VAC5-80-1105; adding 9VAC5-80-1111).

9VAC5-540. Emergency Generator General Permit (amending 9VAC5-540-20, 9VAC5-540-40).

Statutory Authority: § 10.1-1308 of the Code of Virginia; Chapter 344 of the 2025 Acts of Assembly.

Effective Date: June 16, 2025.

Agency Contact: Karen G. Sabasteanski, Department of Environmental Quality, 1111 East Main Street, Suite 1400, P.O. Box 1105, Richmond, VA 23218, telephone (804) 659-1973, or email karen.sabasteanski@deq.virginia.gov.

Summary:

Pursuant to Chapter 344 of the 2025 Acts of Assembly, the amendments allow any affected emergency generator, defined as any emergency generator certified by the U.S. Department of Defense or relevant branch of the U.S. Armed Forces as mission-critical and essential to the defense of the United States, to operate up to 50 hours per year for nonemergency purposes, including planned outages and switch gear and related electrical system testing. These changes comport with the U.S. Environmental Protection Agency's National Emissions Standards for Hazardous Air Pollutants for Stationary Reciprocating Internal Combustion Engines.

9VAC5-80-1105. Permit exemptions.

A. The general requirements for minor NSR permit exemptions are as follows:

1. The provisions of this article do not apply to the following stationary sources or emissions units:

a. The construction of any stationary source or emissions unit that is exempt under the provisions of subsections B through F of this section. In determining whether a source is exempt from the provisions of this article, the provisions of subsections B, C, and D of this section are independent from the provisions of subsections E and F of this section. A source must be determined to be exempt both under the provisions of subsections B, C, and D of this section taken as a group and under the provisions of subsections E and F of this section to be exempt from this article.

b. Vegetative waste recycling/mulching operations that do not exceed 2100 hours of operation in any 12-month consecutive period at a single stationary source. To qualify as an exemption under this subdivision, the total rated capacity of all diesel engines at the source, including portable diesel engines temporarily located at the site, may not exceed 1200 brake horsepower (output).

c. The location of a portable emissions unit at a site subject to the following conditions:

(1) Any new emissions from the portable emissions unit are secondary emissions.

(2) The portable emissions unit is either subject to (i) a minor NSR permit authorizing the emissions unit as a portable emissions unit subject to this subdivision or (ii) a general permit.

(3) The emissions of the portable emissions unit at the site would be temporary.

(4) The portable emissions unit would not undergo modification or replacement that would be subject to this article.

(5) The portable emissions unit is suitable to the area in which it is to be located.

(6) Reasonable notice is given to the department prior to locating the emissions unit to the site identifying the proposed site and the probable duration of operation at the site. Such notice shall be provided to the department not less than 15 days prior to the date the emissions unit is to be located at the site unless a different notification schedule is previously approved by the department.

d. The reactivation of a stationary source unless a determination concerning shutdown has been made pursuant to the provisions of 9VAC5-20-220.

e. The use by any existing stationary source or emissions unit of an alternative fuel or raw material, if the following conditions are met:

(1) The owner demonstrates to the department that, as a result of trial burns at the owner's facility or other facilities or other sufficient data, the emissions resulting from the use of the alternative fuel or raw material supply are decreased. No demonstration will be required for the use of processed animal fat, processed fish oil, processed vegetable oil, distillate oil, or any mixture thereof in place of the same quantity of residual oil to fire industrial boilers.

(2) The use of an alternative fuel or raw material would not be subject to review under this article as a project.

2. The provisions of this article do not apply to the following stationary sources or emissions units provided the stationary source or emissions unit (i) is exempt under the provisions of subsections E and F of this section and (ii) meets any other applicable criteria or conditions set forth in this subdivision.

a. Replacement of an emissions unit subject to the following criteria:

(1) The replacement emissions unit is (i) of an equal or lesser size and (ii) of an equal or lesser rated capacity as compared to the replaced emissions unit.

(2) The replacement emissions unit is functionally equivalent to the replaced emissions unit.

(3) The replacement emissions unit does not change the basic design parameters of the process operation.

(4) The potential to emit of the replacement emissions unit does not exceed the potential to emit of the replaced emissions unit. If the replaced emissions unit is subject to terms and conditions contained in a minor NSR permit, the owner may, concurrently with the notification required in subdivision (6) of this subdivision, request a minor amendment as provided in 9VAC5-80-1280 B 4 to that permit to apply those terms and conditions to the replacement emissions unit. However, the replacement emissions unit's potential to emit is not limited for the purposes of this subdivision unless (and until) the requested minor permit amendment is granted by the department.

(5) The replaced emissions unit is either removed or permanently shut down in accordance with the provisions of 9VAC5-20-220.

(6) The owner notifies the department, in writing, of the proposed replacement at least 15 days prior to commencing construction on the replacement emissions unit. Such notification shall include the size, function, and rated capacity of the existing and replacement emissions units and the registration number of the affected stationary source.

b. A reduction in stack outlet elevation, provided that the stack serves only facilities that have been previously determined to be exempt from the minor NSR program.

3. In determining whether a facility is exempt from the provisions of this article under the provisions of subsection B of this section, the definitions in 9VAC5-40 (Existing Stationary Sources) that would cover the facility if it were an existing source shall be used unless deemed inappropriate by the department.

4. Any owner claiming that a facility is exempt from this article under the provisions of this section shall keep records as may be necessary to demonstrate to the satisfaction of the department that the facility was exempt at the time a minor NSR permit would have otherwise been required under this article.

B. Facilities as specified below shall be exempt from the provisions of this article.

1. Fuel burning equipment units (external combustion units, not engines and turbines) and space heaters in a single application as follows:

a. Except as provided in subdivision b of this subdivision, the exemption thresholds in subdivisions (1) through (4) of this subdivision shall be applied on an individual unit basis for each fuel type.

(1) Using solid fuel with a maximum heat input of less than 1,000,000 Btu per hour.

(2) Using liquid fuel with a maximum heat input of less than 10,000,000 Btu per hour.

(3) Using liquid and gaseous fuel with a maximum heat input of less than 10,000,000 Btu per hour.

(4) Using gaseous fuel with a maximum heat input of less than 50,000,000 Btu per hour.

b. In ozone nonattainment areas designated in 9VAC5-20-204 or ozone maintenance areas designated in 9VAC5-20-203, the exemption thresholds in subdivision a of this subdivision shall be applied in the aggregate for each fuel type.

2. Engines and turbines that are used for emergency purposes only and that do not individually exceed 500 hours of operation per year at a single stationary source and that are used only (i) during an emergency, for required maintenance, for operability and emissions testing, or (ii) as provided by 9VAC5-80-1111 as follows. All engines and turbines in a single application must also meet the following criteria to be exempt.

a. Gasoline engines with an aggregate rated brake (output) horsepower of less than 910 hp and gasoline engines powering electrical generators having an aggregate rated electrical power output of less than 611 kilowatts.

b. Diesel engines with an aggregate rated brake (output) horsepower of less than 1,675 hp and diesel engines powering electrical generators having an aggregate rated electrical power output of less than 1125 kilowatts.

c. Combustion gas turbines with an aggregate of less than 10,000,000 Btu per hour heat input (low heating value).

3. Engines that power mobile sources during periods of maintenance, repair, or testing.

4. Volatile organic compound storage and transfer operations involving petroleum liquids and other volatile organic compounds with a vapor pressure less than 1.5 pounds per square inch absolute under actual storage conditions or, in the case of loading or processing, under actual loading or processing conditions; and any operation specified below:

a. Volatile organic compound transfer operations involving:

(1) Any tank of 2,000 gallons or less storage capacity; or

(2) Any operation outside the volatile organic compound emissions control areas designated in 9VAC5-20-206.

b. Volatile organic compound storage operations involving any tank of 40,000 gallons or less storage capacity.

5. Vehicle customizing coating operations, if production is less than 20 vehicles per day.

6. Vehicle refinishing operations.

7. Coating operations for the exterior of fully assembled aircraft or marine vessels.

8. Petroleum liquid storage and transfer operations involving petroleum liquids with a vapor pressure less than 1.5 pounds per square inch absolute under actual storage conditions or, in the case of loading or processing, under actual loading or processing conditions (kerosene and fuel oil used for household heating have vapor pressures of less than 1.5 pounds per square inch absolute under actual storage conditions; therefore, kerosene and fuel oil are not subject to the provisions of this article when used or stored at ambient temperatures); and any operation or facility specified below:

a. Gasoline bulk loading operations at bulk terminals located outside volatile organic compound emissions control areas designated in 9VAC5-20-206.

b. Gasoline dispensing facilities.

c. Gasoline bulk loading operations at bulk plants:

(1) With an expected daily throughput of less than 4,000 gallons, or

(2) Located outside volatile organic compound emissions control areas designated in 9VAC5-20-206.

d. Account/tank trucks; however, permits issued for gasoline storage/transfer facilities should include a provision that all associated account/tank trucks meet the same requirements as those trucks serving existing facilities.

e. Petroleum liquid storage operations involving:

(1) Any tank of 40,000 gallons or less storage capacity;

(2) Any tank of less than 420,000 gallons storage capacity for crude oil or condensate stored, processed, or treated at a drilling and production facility prior to custody transfer; or

(3) Any tank storing waxy, heavy pour crude oil.

9. Petroleum dry cleaning plants with a total manufacturers' rated solvent dryer capacity less than 84 pounds as determined by the applicable new source performance standard in 9VAC5-50-410.

10. Any addition of, relocation of, or change to a woodworking machine within a wood product manufacturing plant, provided the system air movement capacity, expressed as the cubic feet per minute of air, is not increased and maximum control efficiency of the control system is not decreased.

11. Wood sawmills and planing mills primarily engaged in sawing rough lumber and timber from logs and bolts, or resawing cants and flitches into lumber, including box lumber and softwood cut stock; planing mills combined with sawmills; and separately operated planing mills that are engaged primarily in producing surfaced lumber and standard workings or patterns of lumber. This also includes facilities primarily engaged in sawing lath and railroad ties and in producing tobacco hogshead stock, wood chips, and snow fence lath. This exemption does not include any facility that engages in the kiln drying of lumber.

12. Exhaust flares at natural gas and coalbed methane extraction wells.

13. Temporary facilities subject to the following conditions:

a. The operational period of the temporary facility (the period from the date that the first pollutant-emitting operation is commenced to the date of shutdown of the temporary facility) is 12 months or less.

b. The uncontrolled emissions rate of any regulated air pollutant that would be emitted from the temporary facility during the operational period does not exceed the applicable exempt emission rate as set forth in 9VAC5-80-1105 C (exemption rates for new stationary sources) or 9VAC5-80-1105 D (exemption rates for projects). The uncontrolled emission rate may be calculated based upon the total number of hours in the operational period instead of 8760 hours. All temporary facilities that will be co-located at a stationary source shall be considered in the aggregate when calculating the uncontrolled emissions rate under this subdivision.

c. Upon completion of the operational period, the temporary facility shall be either (i) shut down in accordance with 9VAC5-20-220 or (ii) returned to its original state and condition unless, prior to the end of the operational period, the owner demonstrates in writing to the satisfaction of the department that the facility is exempt under 9VAC5-80-1105 C (exemption rates for new stationary sources) or D (exemption rates for new stationary projects) using 8760 hours of operation per year.

d. Not less than 30 calendar days prior to commencing the operational period, the owner shall notify the department in writing of the proposed temporary facility and shall provide (i) calculations demonstrating that the temporary facility is exempt under this subdivision and under 9VAC5-80-1105 E and F and (ii) proposed dates for commencing the first pollutant-emitting operation and shutdown of the temporary facility.

e. The owner shall provide written notifications to the department of (i) the actual date of commencing the first pollutant-emitting operation and (ii) the actual date of shutdown of the temporary facility. Notifications shall be postmarked or electronically submitted not more than 10 days after such dates.

14. Open pit incinerators subject to 9VAC5-130 (Regulation for Open Burning) and used solely for the purpose of disposal of clean burning waste and debris waste.

15. Poultry or swine incinerators located on a farm where all of the following conditions are met:

a. Auxiliary fuels for the incinerator unit shall be limited to natural gas, liquid petroleum gas, or distilled petroleum liquid fuel. Solid fuels, waste materials, or residual petroleum oil products shall not be used to fire the incinerator.

b. The waste incinerated shall be limited to pathological waste (poultry or swine remains). Litter and animal bedding or any other waste materials shall not be incinerated.

c. The design burn rate or capacity rate of the incinerator shall be 400 pounds per hour or less of poultry or swine. This value shall apply only to the mass of the poultry or swine and shall not include the mass of the fuel.

d. The incinerator shall be used solely to dispose of poultry or swine originating on the farm where the incinerator is located.

e. The incinerator shall be owned and operated by the owner or operator of the farm where the incinerator is located.

f. The incinerator shall not be charged beyond the manufacturer's recommended rated capacity.

g. Records shall be maintained on site to demonstrate compliance with the conditions for this exemption, including the total amount of pathological waste incinerated and the fuel usage on a calendar year quarterly basis.

C. The exemption of new stationary sources shall be determined as specified below:

1. New stationary sources with uncontrolled emission rates less than all of the emission rates specified below shall be exempt from the provisions of this article. The uncontrolled emission rate of a new stationary source is the sum of the uncontrolled emission rates of the individual affected emissions units. Facilities exempted by subsection B of this section shall not be included in the summation of uncontrolled emissions for purposes of exempting new stationary sources under this subsection.

2. If the particulate matter (PM₁₀ or PM_2.5) emissions for a stationary source can be determined in a manner acceptable to the department and the stationary source is deemed exempt using the emission rate for particulate matter (PM₁₀ or PM_2.5), the stationary source shall be considered to be exempt for particulate matter (PM). If the emissions of particulate matter (PM₁₀ or PM_2.5) cannot be determined in a manner acceptable to the department, the emission rate for particulate matter (PM) shall be used to determine the exemption status.

3. The provisions of this article do not apply to a new stationary source if all of the emissions considered in calculating the uncontrolled emission rate of the new stationary source are fugitive emissions.

D. The exemption of projects shall be determined as specified below:

1. A project that would result in increases in uncontrolled emission rates at the stationary source less than all of the emission rates specified below shall be exempt from the provisions of this article. The uncontrolled emission rate increase of a project is the sum of the uncontrolled emission rate increases of the individual affected emissions units. Uncontrolled emissions rate decreases are not considered as part of this calculation. Facilities exempted by subsection B of this section shall not be included in the summation of uncontrolled emissions for purposes of exempting projects under this subsection.

2. If the particulate matter (PM₁₀ or PM_2.5) emissions for a stationary source can be determined in a manner acceptable to the department and the stationary source is deemed exempt using the emission rate for particulate matter (PM₁₀ or PM_2.5), the stationary source shall be considered to be exempt for particulate matter (PM). If the emissions of particulate matter (PM₁₀ or PM_2.5) cannot be determined in a manner acceptable to the department, the emission rate for particulate matter (PM) shall be used to determine the exemption status.

3. The provisions of this article do not apply to a project if all of the emissions considered in calculating the uncontrolled emission rate increase of the project are fugitive emissions.

E. Exemptions for stationary sources of toxic pollutants not subject to the federal hazardous air pollutant new source review program shall be as follows:

1. Stationary sources exempt from the requirements of Article 5 (9VAC5-60-300 et seq.) of Part II of 9VAC5-60 (Hazardous Air Pollutant Sources) as provided in 9VAC5-60-300 C 1, C 2, C 7, D, or E shall be exempt from the provisions of this article.

2. Facilities as specified below shall not be exempt, regardless of size or emission rate, from the provisions of this article.

a. Incinerators, unless (i) the incinerator is used exclusively as air pollution control equipment, (ii) the incinerator is an open pit incinerator subject to 9VAC5-130 (Regulation for Open Burning) and used solely for the disposal of clean burning waste and debris waste, or (iii) the incinerator is a poultry or swine incinerator located on a farm and all of the conditions of subdivision B 15 of this section are met.

b. Ethylene oxide sterilizers.

c. Boilers, incinerators, or industrial furnaces as defined in 40 CFR 260.10 and subject to 9VAC20-60 (Hazardous Waste Regulations).

F. This subsection provides information on the extent to which any source category or portion of a source category subject to the federal hazardous air pollutant new source review program may be exempt from the provisions of this article.

1. This subdivision addresses those source categories subject to the provisions of 40 CFR 61.05, 40 CFR 61.06, 40 CFR 61.07, 40 CFR 61.08, and 40 CFR 61.15 that establish the requirements for issuing approvals of the construction of any new source or modification of any existing source subject to the provisions of 40 CFR Part 61. Any source category or portion of a source category subject to this element of the federal hazardous air pollutant new source review program shall be exempt from the provisions of this article if specifically exempted from that program by 40 CFR Part 61.

2. This subdivision addresses those source categories subject to the provisions of 40 CFR 63.5 that establish the requirements for issuing approvals to construct a new source or reconstruct a source subject to the provisions of 40 CFR Part 63, except for Subparts B, D, and E. Any source category or portion of a source category subject to this element of the federal hazardous air pollutant new source review program shall be exempt from the provisions of this article if specifically exempted from that program by 40 CFR Part 63.

3. This subdivision addresses those source categories subject to the provisions of 40 CFR 63.50 through 40 CFR 63.56 that establish the requirements for issuing notices of MACT approval prior to the construction of a new emissions unit listed in the source category schedule for standards. Any information regarding exemptions for a source category or portion of a source category subject to this element of the federal hazardous air pollutant new source review program may be found in Article 3 (9VAC5-60-120 et seq.) of Part II of 9VAC5-60 (Hazardous Air Pollutant Sources).

4. This subdivision addresses those source categories for which EPA has promulgated a formal determination that no regulations or other requirements need to be established pursuant to § 112 of the federal Clean Air Act in the source category schedule for standards. Any source category or portion of a source category subject to this element of the federal hazardous air pollutant new source review program shall be exempt from the provisions of this article.

9VAC5-80-1111. Emergency generators, certain military installations.

Any emergency generator, whether or not located on a military installation as defined in § 15.2-2201 of the Code of Virginia, that has been certified in accordance with 9VAC5-20-230 by the U.S. Department of Defense or relevant branch of the U.S. Armed Forces to the department as mission-critical and essential to the defense of the United States may operate up to 50 hours per year for nonemergency purposes, including planned outages and switch gear and related electrical system testing. Such nonemergency operation shall be consistent with the requirements for emergency engines pursuant to 40 CFR 60.4211(f)(3), 40 CFR 60.4243(d)(3), and 40 CFR 63.6640(f)(3) and (4). Operation for the purposes identified in clause (i) of 9VAC5-80-1105 B 2 shall not count against the 50 hours per year nonemergency operating allowance provided by this section. Each owner of such emergency generator, whether or not located on a military installation as defined in § 15.2-2201 of the Code of Virginia, shall maintain a copy of each certification, or revision thereof, submitted to the department in accordance with 9VAC5-40-50 or 9VAC5-50-50, as applicable. In accordance with 9VAC5-20-230, any certification shall be revised and submitted to the department upon a determination that the provisions of this section no longer apply. These certifications shall be maintained for the life of each applicable emergency generator.

9VAC5-540-20. Terms defined.

"Affected unit" means one or more emergency generation units subject to the provisions of this chapter.

"Aggregate rated electrical power output" means (i) the sum or total rated electrical power output for all affected units involved in the application or (ii) in nonattainment areas, the sum or total rated electrical output for all affected units, permitted or exempt, located at the facility.

"Attainment area" means any area (other than an area identified as a nonattainment area) that meets the national ambient air quality standards for any pollutant pursuant to § 107 of the federal Clean Air Act (42 USC § 7401 et seq.).

"Biodiesel fuel" means a fuel comprised of mono-alkyl esters of long chain fatty acids derived from vegetable or animal fats, designated B100, and meeting the requirements of ASTM D6751-09.

"Biodiesel blends" means a blend of biodiesel and petroleum diesel fuel meeting either the requirements of ASTM D975-10b (blends up to 5.0%) or ASTM D7467 (blends between 6.0% and 20% biodiesel) and designated Bxx where xx represents the biodiesel content of the blend, e.g., B20 for a blend of 20% biodiesel and 80% petroleum diesel fuel.

"Compression ignition unit" or "CI unit" means a type of stationary internal combustion engine that is not a spark ignition engine.

"Demand response" means measures aimed at shifting time of use of electricity from peak-use periods to times of lower demand by inducing retail customers to curtail electricity usage during periods of congestion and higher prices in the electrical grid. Demand response actions are typically undertaken by the source owner in response to a request from a utility or electrical grid system operator or in response to market prices. Demand response participants do not include affected units that are participating in an ISO's Manual 13 Emergency Operations program.

"Diesel fuel" means any liquid obtained from the distillation of petroleum with a boiling point of approximately 150°C to 360°C and that complies with the specifications for S15 diesel fuel oil, as defined by the American Society for Testing and Materials in ASTM D975-10b.

"Emergency" means a condition that arises from sudden and reasonably unforeseeable events where the primary energy or power source is disrupted or disconnected due to conditions beyond the control of an owner of a source including any of the following:

1. A failure of the electrical grid.

2. On-site disaster or equipment failure.

3. Public service emergencies such as flood, fire, natural disaster, or severe weather conditions.

4. An ISO-declared emergency, where an ISO emergency is any of the following:

a. An abnormal system condition requiring manual or automatic action to maintain system frequency, to prevent loss of firm load, equipment damage, or tripping of system elements that could adversely affect the reliability of an electric system or the safety of persons or property.

b. Capacity deficiency or capacity excess conditions.

c. A fuel shortage requiring departure from normal operating procedures in order to minimize the use of such scarce fuel.

d. Abnormal natural events or man-made threats that would require conservative operations to posture the system in a more reliable state.

e. An abnormal event external to the ISO service territory that may require ISO action.

"Emergency generation unit or source" means a stationary internal combustion engine that operates only (i) during an emergency, required maintenance, or operability and emissions testing, or (ii) as provided by 9VAC5-540-40 B for certified emergency generators.

"General permit" means, for an emergency generation unit, the terms and conditions in Part IV (9VAC5-540-140 et seq.) of this chapter that meet the requirements of Part II (9VAC5-540-30 et seq.) and Part III (9VAC5-540-90 et seq.) of this chapter and issued under the provisions of 9VAC5-80-1250.

"Identical affected unit" means electric generating units that have the same make, manufacturer, model, year, size, and fuel specifications.

"Independent system operator" or "ISO" means a person who may receive or has received by transfer pursuant to § 56-576 of the Code of Virginia, any ownership or control of, or any responsibility to operate, all or part of the transmission systems in the Commonwealth.

"Integration operational period" means that period of time beginning with the first time the affected unit is started on-site and ending when the affected unit is fully integrated with the source's electrical system. In no case shall this period exceed 30 days.

"ISO-declared emergency" means a condition that exists when the independent system operator, as defined in § 56-576 of the Code of Virginia, notifies electric utilities that an emergency exists or may occur and that complies with the definition of "emergency" adopted by the board.

"Kilowatt (kW) to brake horsepower (bhp)" means the conversion of 1 kW = 1.341 bhp.

"Load curtailment" means an action similar to demand response, with the specific removal or reduction of electrical loads for a limited period of time from a utility grid system in response to a request from the utility or electrical grid system operator.

"Major new source review (major NSR) program" means a preconstruction review and permit program (i) for new major stationary sources or major modifications (physical changes or changes in the method of operation), (ii) established to implement the requirements of §§ 112, 165, and 173 of the federal Clean Air Act (42 USC §§ 7401 et seq.) and associated regulations, and (iii) codified in Article 1 (9VAC5-80-50 et seq.), Article 7 (9VAC5-80-1400 et seq.), Article 8 (9VAC5-80-1605 et seq.) and Article 9 (9VAC5-80-2000 et seq.) of Part II (Permit Procedures) of 9VAC5-80 (Permits for Stationary Sources.

"Manufacturer certified emissions" means the emission levels from a stationary compression ignition engine as identified according to the manufacturers' specifications applicable to that engine's family and model year.

"Model year" means either (i) the calendar year in which the engine was originally produced or (ii) the annual new model production period of the engine manufacturer if it is different than the calendar year. This must include January 1 of the calendar year for which the model year is named. It may not begin before January 2 of the previous calendar year and it must end by December 31 of the named calendar year. For an engine that is converted to a stationary engine after being placed into service as a nonroad or other nonstationary engine, model year means the calendar year or new model production period in which the engine was originally produced.

"Nonattainment area" means any area that does not meet the national ambient air quality standards for any pollutant pursuant to § 107 of the federal Clean Air Act (42 USC § 7401 et seq.) and listed in 9VAC5-20-204.

"Operation" means the burning of fuel regardless of whether electricity is generated.

"Peak shaving" means measures aimed solely at shifting time of use of electricity from peak-use periods to times of lower demand by inducing retail customers to curtail electricity usage during periods of congestion and higher prices in the electrical grid. Peak shaving is typically undertaken at a source owner's discretion in order to reduce maximum electrical usage and, therefore, cost of electrical service to the source owner.

"Reference method" means any method of sampling and analyzing for an air pollutant as described in the following EPA regulations:

1. For ambient air quality standards in 9VAC5-30 (Ambient Air Quality Standards): the applicable appendix of 40 CFR Part 50 or any method that has been designated as a reference method in accordance with 40 CFR Part 53, except that it does not include a method for which a reference designation has been canceled in accordance with 40 CFR 53.11 or 40 CFR 53.16;

2. For emission standards in 9VAC5-40 (Existing Stationary Sources) and 9VAC5-50 (New and Modified Stationary Sources): Appendix M of 40 CFR Part 51 or Appendix A of 40 CFR Part 60; or

3. For emission standards in 9VAC5-60 (Hazardous Air Pollutant Sources): Appendix B of 40 CFR Part 61 or Appendix A of 40 CFR Part 63.

"Spark ignition unit" or "SI unit" means a natural gas or liquefied petroleum gas fueled engine or any other type of engine with a spark plug (or other sparking device) and with operating characteristics significantly similar to the theoretical Otto combustion cycle. Spark ignition engines usually use a throttle to regulate intake air flow to control power during normal operation. Dual-fuel engines in which a liquid fuel (typically diesel fuel) is used for compression ignition and gaseous fuel (typically natural gas) is used as the primary fuel at an annual average ratio of less than 2 parts diesel fuel to 100 parts total fuel on an energy equivalent basis are spark ignition engines.

"Startup" means the date on which each affected unit completes the integration operational period, unless an extension for start-up notification as stated in subdivision 4 of 9VAC5-540-210 is approved by the department. An extension request must be submitted seven days prior to the end of the 30-day integration operational period.

"Virginia Air Pollution Control Law" means Chapter 13 (§ 10.1-1300 et seq.) of Title 10.1 of the Code of Virginia.

9VAC5-540-40. Applicability.

A. This chapter applies to each affected unit (i) for which construction, modification, or operation is commenced on or after August 17, 2011; (ii) that does not meet the permit exemption thresholds of 9VAC5-80-1105 B 2 b, C 1, or D 1; and (iii) that meets the requirements of this subsection.

1. For CI units, located in an attainment area with an aggregate rated electrical power output identified in Table I:

2. For CI units, located in a nonattainment area with an aggregate rated electrical power output identified in Table II:

3. For SI units located in an attainment area with an aggregate rated electrical power output less than or equal to 23,535 kW (31,560 bhp).

4. For SI units located in a nonattainment area with an aggregate rated electrical power output less than or equal to 13,115 kW (17,587 bhp).

B. Any emergency generation unit, whether or not located on a military installation as defined in § 15.2-2201 of the Code of Virginia, that has been certified in accordance with 9VAC5-20-230 by the U.S. Department of Defense or relevant branch of the U.S. Armed Forces to the department as mission-critical and essential to the defense of the United States may operate up to 50 hours per year for nonemergency purposes, including planned outages and switch gear and related electrical system testing. Such nonemergency operation shall be consistent with the requirements for emergency engines pursuant to 40 CFR 60.4211(f)(3), 40 CFR 60.4243(d)(3), and 40 CFR 63.6640(f)(3) and (4). Operation for the purposes identified in clause (i) of the definition of emergency generation unit in 9VAC5-540-20 shall not count against the 50 hours per year nonemergency operating allowance provided by this section. Each owner of such emergency generation unit, whether or not located on a military installation as defined in § 15.2-2201 of the Code of Virginia, shall maintain a copy of each certification, or revision thereof, submitted to the department in accordance with 9VAC5-40-50 or 9VAC5-50-50, as applicable. In accordance with 9VAC5-20-230, any certification shall be revised and submitted to the department upon a determination that the provisions of this section no longer apply. These certifications shall be maintained for the life of each applicable emergency generator.

C. This chapter applies throughout the Commonwealth of Virginia.

C. D. The following affected unit or units shall not be eligible for this general permit:

1. Any affected unit that is subject to the provisions of the major new source review program as defined in this chapter.

2. Any affected unit that operates during nonemergency conditions for purposes other than required maintenance and, operability testing, and emissions testing or as provided by subsection B of this section for certified emergency generation units (including but not limited to peak shaving, demand response, or as part of any other interruptible power supply arrangement with a power provider, other market participant, or system operator). An electric generating unit that operates during nonemergency conditions subject to the provisions of subsection B of this section is not prohibited from obtaining a general permit.

TITLE 9. ENVIRONMENT

STATE AIR POLLUTION CONTROL BOARD

Final Regulation

Titles of Regulations: 9VAC5-80. Permits for Stationary Sources (amending 9VAC5-80-1105; adding 9VAC5-80-1111).

9VAC5-540. Emergency Generator General Permit (amending 9VAC5-540-20, 9VAC5-540-40).

Statutory Authority: § 10.1-1308 of the Code of Virginia; Chapter 344 of the 2025 Acts of Assembly.

Effective Date: June 16, 2025.

Agency Contact: Karen G. Sabasteanski, Department of Environmental Quality, 1111 East Main Street, Suite 1400, P.O. Box 1105, Richmond, VA 23218, telephone (804) 659-1973, or email karen.sabasteanski@deq.virginia.gov.

Summary:

Pursuant to Chapter 344 of the 2025 Acts of Assembly, the amendments allow any affected emergency generator, defined as any emergency generator certified by the U.S. Department of Defense or relevant branch of the U.S. Armed Forces as mission-critical and essential to the defense of the United States, to operate up to 50 hours per year for nonemergency purposes, including planned outages and switch gear and related electrical system testing. These changes comport with the U.S. Environmental Protection Agency's National Emissions Standards for Hazardous Air Pollutants for Stationary Reciprocating Internal Combustion Engines.

9VAC5-80-1105. Permit exemptions.

A. The general requirements for minor NSR permit exemptions are as follows:

1. The provisions of this article do not apply to the following stationary sources or emissions units:

a. The construction of any stationary source or emissions unit that is exempt under the provisions of subsections B through F of this section. In determining whether a source is exempt from the provisions of this article, the provisions of subsections B, C, and D of this section are independent from the provisions of subsections E and F of this section. A source must be determined to be exempt both under the provisions of subsections B, C, and D of this section taken as a group and under the provisions of subsections E and F of this section to be exempt from this article.

b. Vegetative waste recycling/mulching operations that do not exceed 2100 hours of operation in any 12-month consecutive period at a single stationary source. To qualify as an exemption under this subdivision, the total rated capacity of all diesel engines at the source, including portable diesel engines temporarily located at the site, may not exceed 1200 brake horsepower (output).

c. The location of a portable emissions unit at a site subject to the following conditions:

(1) Any new emissions from the portable emissions unit are secondary emissions.

(2) The portable emissions unit is either subject to (i) a minor NSR permit authorizing the emissions unit as a portable emissions unit subject to this subdivision or (ii) a general permit.

(3) The emissions of the portable emissions unit at the site would be temporary.

(4) The portable emissions unit would not undergo modification or replacement that would be subject to this article.

(5) The portable emissions unit is suitable to the area in which it is to be located.

(6) Reasonable notice is given to the department prior to locating the emissions unit to the site identifying the proposed site and the probable duration of operation at the site. Such notice shall be provided to the department not less than 15 days prior to the date the emissions unit is to be located at the site unless a different notification schedule is previously approved by the department.

d. The reactivation of a stationary source unless a determination concerning shutdown has been made pursuant to the provisions of 9VAC5-20-220.

e. The use by any existing stationary source or emissions unit of an alternative fuel or raw material, if the following conditions are met:

(1) The owner demonstrates to the department that, as a result of trial burns at the owner's facility or other facilities or other sufficient data, the emissions resulting from the use of the alternative fuel or raw material supply are decreased. No demonstration will be required for the use of processed animal fat, processed fish oil, processed vegetable oil, distillate oil, or any mixture thereof in place of the same quantity of residual oil to fire industrial boilers.

(2) The use of an alternative fuel or raw material would not be subject to review under this article as a project.

2. The provisions of this article do not apply to the following stationary sources or emissions units provided the stationary source or emissions unit (i) is exempt under the provisions of subsections E and F of this section and (ii) meets any other applicable criteria or conditions set forth in this subdivision.

a. Replacement of an emissions unit subject to the following criteria:

(1) The replacement emissions unit is (i) of an equal or lesser size and (ii) of an equal or lesser rated capacity as compared to the replaced emissions unit.

(2) The replacement emissions unit is functionally equivalent to the replaced emissions unit.

(3) The replacement emissions unit does not change the basic design parameters of the process operation.

(4) The potential to emit of the replacement emissions unit does not exceed the potential to emit of the replaced emissions unit. If the replaced emissions unit is subject to terms and conditions contained in a minor NSR permit, the owner may, concurrently with the notification required in subdivision (6) of this subdivision, request a minor amendment as provided in 9VAC5-80-1280 B 4 to that permit to apply those terms and conditions to the replacement emissions unit. However, the replacement emissions unit's potential to emit is not limited for the purposes of this subdivision unless (and until) the requested minor permit amendment is granted by the department.

(5) The replaced emissions unit is either removed or permanently shut down in accordance with the provisions of 9VAC5-20-220.

(6) The owner notifies the department, in writing, of the proposed replacement at least 15 days prior to commencing construction on the replacement emissions unit. Such notification shall include the size, function, and rated capacity of the existing and replacement emissions units and the registration number of the affected stationary source.

b. A reduction in stack outlet elevation, provided that the stack serves only facilities that have been previously determined to be exempt from the minor NSR program.

3. In determining whether a facility is exempt from the provisions of this article under the provisions of subsection B of this section, the definitions in 9VAC5-40 (Existing Stationary Sources) that would cover the facility if it were an existing source shall be used unless deemed inappropriate by the department.

4. Any owner claiming that a facility is exempt from this article under the provisions of this section shall keep records as may be necessary to demonstrate to the satisfaction of the department that the facility was exempt at the time a minor NSR permit would have otherwise been required under this article.

B. Facilities as specified below shall be exempt from the provisions of this article.

1. Fuel burning equipment units (external combustion units, not engines and turbines) and space heaters in a single application as follows:

a. Except as provided in subdivision b of this subdivision, the exemption thresholds in subdivisions (1) through (4) of this subdivision shall be applied on an individual unit basis for each fuel type.

(1) Using solid fuel with a maximum heat input of less than 1,000,000 Btu per hour.

(2) Using liquid fuel with a maximum heat input of less than 10,000,000 Btu per hour.

(3) Using liquid and gaseous fuel with a maximum heat input of less than 10,000,000 Btu per hour.

(4) Using gaseous fuel with a maximum heat input of less than 50,000,000 Btu per hour.

b. In ozone nonattainment areas designated in 9VAC5-20-204 or ozone maintenance areas designated in 9VAC5-20-203, the exemption thresholds in subdivision a of this subdivision shall be applied in the aggregate for each fuel type.

2. Engines and turbines that are used for emergency purposes only and that do not individually exceed 500 hours of operation per year at a single stationary source and that are used only (i) during an emergency, for required maintenance, for operability and emissions testing, or (ii) as provided by 9VAC5-80-1111 as follows. All engines and turbines in a single application must also meet the following criteria to be exempt.

a. Gasoline engines with an aggregate rated brake (output) horsepower of less than 910 hp and gasoline engines powering electrical generators having an aggregate rated electrical power output of less than 611 kilowatts.

b. Diesel engines with an aggregate rated brake (output) horsepower of less than 1,675 hp and diesel engines powering electrical generators having an aggregate rated electrical power output of less than 1125 kilowatts.

c. Combustion gas turbines with an aggregate of less than 10,000,000 Btu per hour heat input (low heating value).

3. Engines that power mobile sources during periods of maintenance, repair, or testing.

4. Volatile organic compound storage and transfer operations involving petroleum liquids and other volatile organic compounds with a vapor pressure less than 1.5 pounds per square inch absolute under actual storage conditions or, in the case of loading or processing, under actual loading or processing conditions; and any operation specified below:

a. Volatile organic compound transfer operations involving:

(1) Any tank of 2,000 gallons or less storage capacity; or

(2) Any operation outside the volatile organic compound emissions control areas designated in 9VAC5-20-206.

b. Volatile organic compound storage operations involving any tank of 40,000 gallons or less storage capacity.

5. Vehicle customizing coating operations, if production is less than 20 vehicles per day.

6. Vehicle refinishing operations.

7. Coating operations for the exterior of fully assembled aircraft or marine vessels.

8. Petroleum liquid storage and transfer operations involving petroleum liquids with a vapor pressure less than 1.5 pounds per square inch absolute under actual storage conditions or, in the case of loading or processing, under actual loading or processing conditions (kerosene and fuel oil used for household heating have vapor pressures of less than 1.5 pounds per square inch absolute under actual storage conditions; therefore, kerosene and fuel oil are not subject to the provisions of this article when used or stored at ambient temperatures); and any operation or facility specified below:

a. Gasoline bulk loading operations at bulk terminals located outside volatile organic compound emissions control areas designated in 9VAC5-20-206.

b. Gasoline dispensing facilities.

c. Gasoline bulk loading operations at bulk plants:

(1) With an expected daily throughput of less than 4,000 gallons, or

(2) Located outside volatile organic compound emissions control areas designated in 9VAC5-20-206.

d. Account/tank trucks; however, permits issued for gasoline storage/transfer facilities should include a provision that all associated account/tank trucks meet the same requirements as those trucks serving existing facilities.

e. Petroleum liquid storage operations involving:

(1) Any tank of 40,000 gallons or less storage capacity;

(2) Any tank of less than 420,000 gallons storage capacity for crude oil or condensate stored, processed, or treated at a drilling and production facility prior to custody transfer; or

(3) Any tank storing waxy, heavy pour crude oil.

9. Petroleum dry cleaning plants with a total manufacturers' rated solvent dryer capacity less than 84 pounds as determined by the applicable new source performance standard in 9VAC5-50-410.

10. Any addition of, relocation of, or change to a woodworking machine within a wood product manufacturing plant, provided the system air movement capacity, expressed as the cubic feet per minute of air, is not increased and maximum control efficiency of the control system is not decreased.

11. Wood sawmills and planing mills primarily engaged in sawing rough lumber and timber from logs and bolts, or resawing cants and flitches into lumber, including box lumber and softwood cut stock; planing mills combined with sawmills; and separately operated planing mills that are engaged primarily in producing surfaced lumber and standard workings or patterns of lumber. This also includes facilities primarily engaged in sawing lath and railroad ties and in producing tobacco hogshead stock, wood chips, and snow fence lath. This exemption does not include any facility that engages in the kiln drying of lumber.

12. Exhaust flares at natural gas and coalbed methane extraction wells.

13. Temporary facilities subject to the following conditions:

a. The operational period of the temporary facility (the period from the date that the first pollutant-emitting operation is commenced to the date of shutdown of the temporary facility) is 12 months or less.

b. The uncontrolled emissions rate of any regulated air pollutant that would be emitted from the temporary facility during the operational period does not exceed the applicable exempt emission rate as set forth in 9VAC5-80-1105 C (exemption rates for new stationary sources) or 9VAC5-80-1105 D (exemption rates for projects). The uncontrolled emission rate may be calculated based upon the total number of hours in the operational period instead of 8760 hours. All temporary facilities that will be co-located at a stationary source shall be considered in the aggregate when calculating the uncontrolled emissions rate under this subdivision.

c. Upon completion of the operational period, the temporary facility shall be either (i) shut down in accordance with 9VAC5-20-220 or (ii) returned to its original state and condition unless, prior to the end of the operational period, the owner demonstrates in writing to the satisfaction of the department that the facility is exempt under 9VAC5-80-1105 C (exemption rates for new stationary sources) or D (exemption rates for new stationary projects) using 8760 hours of operation per year.

d. Not less than 30 calendar days prior to commencing the operational period, the owner shall notify the department in writing of the proposed temporary facility and shall provide (i) calculations demonstrating that the temporary facility is exempt under this subdivision and under 9VAC5-80-1105 E and F and (ii) proposed dates for commencing the first pollutant-emitting operation and shutdown of the temporary facility.

e. The owner shall provide written notifications to the department of (i) the actual date of commencing the first pollutant-emitting operation and (ii) the actual date of shutdown of the temporary facility. Notifications shall be postmarked or electronically submitted not more than 10 days after such dates.

14. Open pit incinerators subject to 9VAC5-130 (Regulation for Open Burning) and used solely for the purpose of disposal of clean burning waste and debris waste.

15. Poultry or swine incinerators located on a farm where all of the following conditions are met:

a. Auxiliary fuels for the incinerator unit shall be limited to natural gas, liquid petroleum gas, or distilled petroleum liquid fuel. Solid fuels, waste materials, or residual petroleum oil products shall not be used to fire the incinerator.

b. The waste incinerated shall be limited to pathological waste (poultry or swine remains). Litter and animal bedding or any other waste materials shall not be incinerated.

c. The design burn rate or capacity rate of the incinerator shall be 400 pounds per hour or less of poultry or swine. This value shall apply only to the mass of the poultry or swine and shall not include the mass of the fuel.

d. The incinerator shall be used solely to dispose of poultry or swine originating on the farm where the incinerator is located.

e. The incinerator shall be owned and operated by the owner or operator of the farm where the incinerator is located.

f. The incinerator shall not be charged beyond the manufacturer's recommended rated capacity.

g. Records shall be maintained on site to demonstrate compliance with the conditions for this exemption, including the total amount of pathological waste incinerated and the fuel usage on a calendar year quarterly basis.

C. The exemption of new stationary sources shall be determined as specified below:

1. New stationary sources with uncontrolled emission rates less than all of the emission rates specified below shall be exempt from the provisions of this article. The uncontrolled emission rate of a new stationary source is the sum of the uncontrolled emission rates of the individual affected emissions units. Facilities exempted by subsection B of this section shall not be included in the summation of uncontrolled emissions for purposes of exempting new stationary sources under this subsection.

2. If the particulate matter (PM₁₀ or PM_2.5) emissions for a stationary source can be determined in a manner acceptable to the department and the stationary source is deemed exempt using the emission rate for particulate matter (PM₁₀ or PM_2.5), the stationary source shall be considered to be exempt for particulate matter (PM). If the emissions of particulate matter (PM₁₀ or PM_2.5) cannot be determined in a manner acceptable to the department, the emission rate for particulate matter (PM) shall be used to determine the exemption status.

3. The provisions of this article do not apply to a new stationary source if all of the emissions considered in calculating the uncontrolled emission rate of the new stationary source are fugitive emissions.

D. The exemption of projects shall be determined as specified below:

1. A project that would result in increases in uncontrolled emission rates at the stationary source less than all of the emission rates specified below shall be exempt from the provisions of this article. The uncontrolled emission rate increase of a project is the sum of the uncontrolled emission rate increases of the individual affected emissions units. Uncontrolled emissions rate decreases are not considered as part of this calculation. Facilities exempted by subsection B of this section shall not be included in the summation of uncontrolled emissions for purposes of exempting projects under this subsection.

2. If the particulate matter (PM₁₀ or PM_2.5) emissions for a stationary source can be determined in a manner acceptable to the department and the stationary source is deemed exempt using the emission rate for particulate matter (PM₁₀ or PM_2.5), the stationary source shall be considered to be exempt for particulate matter (PM). If the emissions of particulate matter (PM₁₀ or PM_2.5) cannot be determined in a manner acceptable to the department, the emission rate for particulate matter (PM) shall be used to determine the exemption status.

3. The provisions of this article do not apply to a project if all of the emissions considered in calculating the uncontrolled emission rate increase of the project are fugitive emissions.

E. Exemptions for stationary sources of toxic pollutants not subject to the federal hazardous air pollutant new source review program shall be as follows:

1. Stationary sources exempt from the requirements of Article 5 (9VAC5-60-300 et seq.) of Part II of 9VAC5-60 (Hazardous Air Pollutant Sources) as provided in 9VAC5-60-300 C 1, C 2, C 7, D, or E shall be exempt from the provisions of this article.

2. Facilities as specified below shall not be exempt, regardless of size or emission rate, from the provisions of this article.

a. Incinerators, unless (i) the incinerator is used exclusively as air pollution control equipment, (ii) the incinerator is an open pit incinerator subject to 9VAC5-130 (Regulation for Open Burning) and used solely for the disposal of clean burning waste and debris waste, or (iii) the incinerator is a poultry or swine incinerator located on a farm and all of the conditions of subdivision B 15 of this section are met.

b. Ethylene oxide sterilizers.

c. Boilers, incinerators, or industrial furnaces as defined in 40 CFR 260.10 and subject to 9VAC20-60 (Hazardous Waste Regulations).

F. This subsection provides information on the extent to which any source category or portion of a source category subject to the federal hazardous air pollutant new source review program may be exempt from the provisions of this article.

1. This subdivision addresses those source categories subject to the provisions of 40 CFR 61.05, 40 CFR 61.06, 40 CFR 61.07, 40 CFR 61.08, and 40 CFR 61.15 that establish the requirements for issuing approvals of the construction of any new source or modification of any existing source subject to the provisions of 40 CFR Part 61. Any source category or portion of a source category subject to this element of the federal hazardous air pollutant new source review program shall be exempt from the provisions of this article if specifically exempted from that program by 40 CFR Part 61.

2. This subdivision addresses those source categories subject to the provisions of 40 CFR 63.5 that establish the requirements for issuing approvals to construct a new source or reconstruct a source subject to the provisions of 40 CFR Part 63, except for Subparts B, D, and E. Any source category or portion of a source category subject to this element of the federal hazardous air pollutant new source review program shall be exempt from the provisions of this article if specifically exempted from that program by 40 CFR Part 63.

3. This subdivision addresses those source categories subject to the provisions of 40 CFR 63.50 through 40 CFR 63.56 that establish the requirements for issuing notices of MACT approval prior to the construction of a new emissions unit listed in the source category schedule for standards. Any information regarding exemptions for a source category or portion of a source category subject to this element of the federal hazardous air pollutant new source review program may be found in Article 3 (9VAC5-60-120 et seq.) of Part II of 9VAC5-60 (Hazardous Air Pollutant Sources).

4. This subdivision addresses those source categories for which EPA has promulgated a formal determination that no regulations or other requirements need to be established pursuant to § 112 of the federal Clean Air Act in the source category schedule for standards. Any source category or portion of a source category subject to this element of the federal hazardous air pollutant new source review program shall be exempt from the provisions of this article.

9VAC5-80-1111. Emergency generators, certain military installations.

Any emergency generator, whether or not located on a military installation as defined in § 15.2-2201 of the Code of Virginia, that has been certified in accordance with 9VAC5-20-230 by the U.S. Department of Defense or relevant branch of the U.S. Armed Forces to the department as mission-critical and essential to the defense of the United States may operate up to 50 hours per year for nonemergency purposes, including planned outages and switch gear and related electrical system testing. Such nonemergency operation shall be consistent with the requirements for emergency engines pursuant to 40 CFR 60.4211(f)(3), 40 CFR 60.4243(d)(3), and 40 CFR 63.6640(f)(3) and (4). Operation for the purposes identified in clause (i) of 9VAC5-80-1105 B 2 shall not count against the 50 hours per year nonemergency operating allowance provided by this section. Each owner of such emergency generator, whether or not located on a military installation as defined in § 15.2-2201 of the Code of Virginia, shall maintain a copy of each certification, or revision thereof, submitted to the department in accordance with 9VAC5-40-50 or 9VAC5-50-50, as applicable. In accordance with 9VAC5-20-230, any certification shall be revised and submitted to the department upon a determination that the provisions of this section no longer apply. These certifications shall be maintained for the life of each applicable emergency generator.

9VAC5-540-20. Terms defined.

"Affected unit" means one or more emergency generation units subject to the provisions of this chapter.

"Aggregate rated electrical power output" means (i) the sum or total rated electrical power output for all affected units involved in the application or (ii) in nonattainment areas, the sum or total rated electrical output for all affected units, permitted or exempt, located at the facility.

"Attainment area" means any area (other than an area identified as a nonattainment area) that meets the national ambient air quality standards for any pollutant pursuant to § 107 of the federal Clean Air Act (42 USC § 7401 et seq.).

"Biodiesel fuel" means a fuel comprised of mono-alkyl esters of long chain fatty acids derived from vegetable or animal fats, designated B100, and meeting the requirements of ASTM D6751-09.

"Biodiesel blends" means a blend of biodiesel and petroleum diesel fuel meeting either the requirements of ASTM D975-10b (blends up to 5.0%) or ASTM D7467 (blends between 6.0% and 20% biodiesel) and designated Bxx where xx represents the biodiesel content of the blend, e.g., B20 for a blend of 20% biodiesel and 80% petroleum diesel fuel.

"Compression ignition unit" or "CI unit" means a type of stationary internal combustion engine that is not a spark ignition engine.

"Demand response" means measures aimed at shifting time of use of electricity from peak-use periods to times of lower demand by inducing retail customers to curtail electricity usage during periods of congestion and higher prices in the electrical grid. Demand response actions are typically undertaken by the source owner in response to a request from a utility or electrical grid system operator or in response to market prices. Demand response participants do not include affected units that are participating in an ISO's Manual 13 Emergency Operations program.

"Diesel fuel" means any liquid obtained from the distillation of petroleum with a boiling point of approximately 150°C to 360°C and that complies with the specifications for S15 diesel fuel oil, as defined by the American Society for Testing and Materials in ASTM D975-10b.

"Emergency" means a condition that arises from sudden and reasonably unforeseeable events where the primary energy or power source is disrupted or disconnected due to conditions beyond the control of an owner of a source including any of the following:

1. A failure of the electrical grid.

2. On-site disaster or equipment failure.

3. Public service emergencies such as flood, fire, natural disaster, or severe weather conditions.

4. An ISO-declared emergency, where an ISO emergency is any of the following:

a. An abnormal system condition requiring manual or automatic action to maintain system frequency, to prevent loss of firm load, equipment damage, or tripping of system elements that could adversely affect the reliability of an electric system or the safety of persons or property.

b. Capacity deficiency or capacity excess conditions.

c. A fuel shortage requiring departure from normal operating procedures in order to minimize the use of such scarce fuel.

d. Abnormal natural events or man-made threats that would require conservative operations to posture the system in a more reliable state.

e. An abnormal event external to the ISO service territory that may require ISO action.

"Emergency generation unit or source" means a stationary internal combustion engine that operates only (i) during an emergency, required maintenance, or operability and emissions testing, or (ii) as provided by 9VAC5-540-40 B for certified emergency generators.

"General permit" means, for an emergency generation unit, the terms and conditions in Part IV (9VAC5-540-140 et seq.) of this chapter that meet the requirements of Part II (9VAC5-540-30 et seq.) and Part III (9VAC5-540-90 et seq.) of this chapter and issued under the provisions of 9VAC5-80-1250.

"Identical affected unit" means electric generating units that have the same make, manufacturer, model, year, size, and fuel specifications.

"Independent system operator" or "ISO" means a person who may receive or has received by transfer pursuant to § 56-576 of the Code of Virginia, any ownership or control of, or any responsibility to operate, all or part of the transmission systems in the Commonwealth.

"Integration operational period" means that period of time beginning with the first time the affected unit is started on-site and ending when the affected unit is fully integrated with the source's electrical system. In no case shall this period exceed 30 days.

"ISO-declared emergency" means a condition that exists when the independent system operator, as defined in § 56-576 of the Code of Virginia, notifies electric utilities that an emergency exists or may occur and that complies with the definition of "emergency" adopted by the board.

"Kilowatt (kW) to brake horsepower (bhp)" means the conversion of 1 kW = 1.341 bhp.

"Load curtailment" means an action similar to demand response, with the specific removal or reduction of electrical loads for a limited period of time from a utility grid system in response to a request from the utility or electrical grid system operator.

"Major new source review (major NSR) program" means a preconstruction review and permit program (i) for new major stationary sources or major modifications (physical changes or changes in the method of operation), (ii) established to implement the requirements of §§ 112, 165, and 173 of the federal Clean Air Act (42 USC §§ 7401 et seq.) and associated regulations, and (iii) codified in Article 1 (9VAC5-80-50 et seq.), Article 7 (9VAC5-80-1400 et seq.), Article 8 (9VAC5-80-1605 et seq.) and Article 9 (9VAC5-80-2000 et seq.) of Part II (Permit Procedures) of 9VAC5-80 (Permits for Stationary Sources.

"Manufacturer certified emissions" means the emission levels from a stationary compression ignition engine as identified according to the manufacturers' specifications applicable to that engine's family and model year.

"Model year" means either (i) the calendar year in which the engine was originally produced or (ii) the annual new model production period of the engine manufacturer if it is different than the calendar year. This must include January 1 of the calendar year for which the model year is named. It may not begin before January 2 of the previous calendar year and it must end by December 31 of the named calendar year. For an engine that is converted to a stationary engine after being placed into service as a nonroad or other nonstationary engine, model year means the calendar year or new model production period in which the engine was originally produced.

"Nonattainment area" means any area that does not meet the national ambient air quality standards for any pollutant pursuant to § 107 of the federal Clean Air Act (42 USC § 7401 et seq.) and listed in 9VAC5-20-204.

"Operation" means the burning of fuel regardless of whether electricity is generated.

"Peak shaving" means measures aimed solely at shifting time of use of electricity from peak-use periods to times of lower demand by inducing retail customers to curtail electricity usage during periods of congestion and higher prices in the electrical grid. Peak shaving is typically undertaken at a source owner's discretion in order to reduce maximum electrical usage and, therefore, cost of electrical service to the source owner.

"Reference method" means any method of sampling and analyzing for an air pollutant as described in the following EPA regulations:

1. For ambient air quality standards in 9VAC5-30 (Ambient Air Quality Standards): the applicable appendix of 40 CFR Part 50 or any method that has been designated as a reference method in accordance with 40 CFR Part 53, except that it does not include a method for which a reference designation has been canceled in accordance with 40 CFR 53.11 or 40 CFR 53.16;

2. For emission standards in 9VAC5-40 (Existing Stationary Sources) and 9VAC5-50 (New and Modified Stationary Sources): Appendix M of 40 CFR Part 51 or Appendix A of 40 CFR Part 60; or

3. For emission standards in 9VAC5-60 (Hazardous Air Pollutant Sources): Appendix B of 40 CFR Part 61 or Appendix A of 40 CFR Part 63.

"Spark ignition unit" or "SI unit" means a natural gas or liquefied petroleum gas fueled engine or any other type of engine with a spark plug (or other sparking device) and with operating characteristics significantly similar to the theoretical Otto combustion cycle. Spark ignition engines usually use a throttle to regulate intake air flow to control power during normal operation. Dual-fuel engines in which a liquid fuel (typically diesel fuel) is used for compression ignition and gaseous fuel (typically natural gas) is used as the primary fuel at an annual average ratio of less than 2 parts diesel fuel to 100 parts total fuel on an energy equivalent basis are spark ignition engines.

"Startup" means the date on which each affected unit completes the integration operational period, unless an extension for start-up notification as stated in subdivision 4 of 9VAC5-540-210 is approved by the department. An extension request must be submitted seven days prior to the end of the 30-day integration operational period.

"Virginia Air Pollution Control Law" means Chapter 13 (§ 10.1-1300 et seq.) of Title 10.1 of the Code of Virginia.

9VAC5-540-40. Applicability.

A. This chapter applies to each affected unit (i) for which construction, modification, or operation is commenced on or after August 17, 2011; (ii) that does not meet the permit exemption thresholds of 9VAC5-80-1105 B 2 b, C 1, or D 1; and (iii) that meets the requirements of this subsection.

1. For CI units, located in an attainment area with an aggregate rated electrical power output identified in Table I:

2. For CI units, located in a nonattainment area with an aggregate rated electrical power output identified in Table II:

3. For SI units located in an attainment area with an aggregate rated electrical power output less than or equal to 23,535 kW (31,560 bhp).

4. For SI units located in a nonattainment area with an aggregate rated electrical power output less than or equal to 13,115 kW (17,587 bhp).

B. Any emergency generation unit, whether or not located on a military installation as defined in § 15.2-2201 of the Code of Virginia, that has been certified in accordance with 9VAC5-20-230 by the U.S. Department of Defense or relevant branch of the U.S. Armed Forces to the department as mission-critical and essential to the defense of the United States may operate up to 50 hours per year for nonemergency purposes, including planned outages and switch gear and related electrical system testing. Such nonemergency operation shall be consistent with the requirements for emergency engines pursuant to 40 CFR 60.4211(f)(3), 40 CFR 60.4243(d)(3), and 40 CFR 63.6640(f)(3) and (4). Operation for the purposes identified in clause (i) of the definition of emergency generation unit in 9VAC5-540-20 shall not count against the 50 hours per year nonemergency operating allowance provided by this section. Each owner of such emergency generation unit, whether or not located on a military installation as defined in § 15.2-2201 of the Code of Virginia, shall maintain a copy of each certification, or revision thereof, submitted to the department in accordance with 9VAC5-40-50 or 9VAC5-50-50, as applicable. In accordance with 9VAC5-20-230, any certification shall be revised and submitted to the department upon a determination that the provisions of this section no longer apply. These certifications shall be maintained for the life of each applicable emergency generator.

C. This chapter applies throughout the Commonwealth of Virginia.

C. D. The following affected unit or units shall not be eligible for this general permit:

1. Any affected unit that is subject to the provisions of the major new source review program as defined in this chapter.

2. Any affected unit that operates during nonemergency conditions for purposes other than required maintenance and, operability testing, and emissions testing or as provided by subsection B of this section for certified emergency generation units (including but not limited to peak shaving, demand response, or as part of any other interruptible power supply arrangement with a power provider, other market participant, or system operator). An electric generating unit that operates during nonemergency conditions subject to the provisions of subsection B of this section is not prohibited from obtaining a general permit.

TITLE 9. ENVIRONMENT

STATE WATER CONTROL BOARD

Final Regulation

Titles of Regulations: 9VAC25-210. Virginia Water Protection Permit Program Regulation (amending 9VAC25-210-300, 9VAC25-210-340).

9VAC25-610. Groundwater Withdrawal Regulations (amending 9VAC25-610-10, 9VAC25-610-100).

Statutory Authority: § 62.1-44.15 of the Code of Virginia; § 401 of the Clean Water Act (33 USC § 1251 et seq.).

Effective Date: August 13, 2025.

Agency Contact: Eric Seavey, Department of Environmental Quality, 1111 East Main Street, Suite 1400, P.O. Box 1105, Richmond, VA 23218, telephone (804) 754-6250, or email eric.seavey@deq.virginia.gov.

Summary:

Pursuant to Chapter 100 of the 2021 Acts of Assembly, Special Session I, and as required by the third enactment clause of Chapter 100 to make the first enactment clause of Chapter 100 effective, the amendments require that any application for a permit to withdraw surface water as provided in 9VAC25-210 or groundwater as provided in 9VAC25-610 include (i) a water auditing plan and (ii) a leak detection plan.

Summary of Public Comments and Agency's Response: A summary of comments made by the public and the agency's response may be obtained from the promulgating agency or viewed at the office of the Registrar of Regulations.

9VAC25-210-300. Definitions for surface water withdrawals.

The following words and terms when used in this part shall have the following meanings:

"Affected stream reach" means the portion of a surface water body beginning at the location of a withdrawal and ending at a point where effects of the withdrawal are not reasonably expected to adversely affect beneficial uses.

"Agricultural surface water withdrawal" means a withdrawal of surface water in Virginia or from the Potomac River for the purpose of agricultural, silvicultural, horticultural, or aquacultural operations. Agricultural surface water withdrawals include withdrawals for turf farm operations, but do not include withdrawals for landscaping activities, or turf installment and maintenance associated with landscaping activities.

"Consumptive use" means any use of water withdrawn from a surface water other than a nonconsumptive use.

"Drought" means the declaration of a drought stage by the Virginia Drought Coordinator or the Governor of Virginia for a particular area or locality within Virginia. Drought stage declarations include watch, warning, and emergency, depending upon severity, as defined by the Virginia Drought Assessment and Response Plan dated March 28, 2003.

"Drought of record" means the time period during which the most severe drought conditions occurred for a particular area or location, as indicated by the available hydrologic and meteorologic data.

"Emergency Virginia Water Protection Permit" means a Virginia Water Protection Permit issued pursuant to § 62.1-44.15:22 C of the Code of Virginia authorizing a new or increased surface water withdrawal to address insufficient public drinking water supplies that are caused by a drought and may result in a substantial threat to human health or public safety.

"Human consumption" means the use of water to support human survival and health, including drinking, bathing, showering, cooking, dishwashing, and maintaining hygiene.

"Instream flow" means the existing volume of water flowing in a stream or water body, including any seasonal variations of water levels and flow.

"Intake structure" means any portion of a surface water withdrawal system used to withdraw surface water that is located within the surface water, such as, but not limited to, a pipe, culvert, hose, tube, or screen.

"Major river basin" means the Potomac-Shenandoah River Basin, the Rappahannock River Basin, the York River Basin, the James River Basin, the Chowan River Basin, the Roanoke River Basin, the New River Basin, or the Tennessee-Big Sandy River Basin.

"Nonconsumptive use" means the use of water withdrawn from a surface water in such a manner that it is returned to the surface water without substantial diminution in quantity at or near the point from which it was taken and would not result in or exacerbate low flow conditions.

"Potomac River Low Flow Allocation Agreement" means the agreement among the United States of America, the State of Maryland, the Commonwealth of Virginia, the District of Columbia, the Washington Suburban Sanitation Commission, and the Fairfax County Water Authority dated January 11, 1978, consented to by the United States Congress in § 181 of the Water Resources Development Act of 1976, Public Law 94-587, as modified on April 22, 1986.

"Public water supply" means a withdrawal of surface water in Virginia or from the Potomac River for the production of drinking water, distributed to the general public for the purpose of, but not limited to, domestic use.

"Public water supply emergency" means a substantial threat to public health or safety due to insufficient public drinking water supplies caused by drought.

"Section for Cooperative Water Supply Operations on the Potomac" means a section of the Interstate Commission on the Potomac River Basin designated by the Water Supply Coordination Agreement as responsible for coordination of water resources during times of low flow in the Potomac River.

"Surface water withdrawal" means a removal or diversion of surface water in Virginia or from the Potomac River for consumptive or nonconsumptive use thereby altering the instream flow or hydrologic regime of the surface water. Projects that do not alter the instream flow or that alter the instream flow but whose sole purpose is flood control or stormwater management are not included in this definition.

"Surface water withdrawal system" means any device or combination of devices used to withdraw surface water such as, but not limited to, a machine, pump, culvert, hose, tube, screen, or fabricated concrete or metal structure.

"Variance" means a mechanism that allows temporary waiver of the generally applicable withdrawal limitation requirements or instream flow conditions of a VWP permit during a drought.

"Water loss" means the difference between the estimated or measured volume of water withdrawn and the estimated or measured volume applied to the beneficial use.

"Water loss audit" means the review of records and data that traces the flow of water from its withdrawal through distribution and application to the beneficial use.

"Water Supply Coordination Agreement" means the agreement among the United States of America, the Fairfax County Water Authority, the Washington Suburban Sanitary Commission, the District of Columbia, and the Interstate Commission on the Potomac River Basin, dated July 22, 1982, which establishes agreement among the suppliers to operate their respective water supply systems in a coordinated manner and which outlines operating rules and procedures for reducing impacts of severe droughts in the Potomac River Basin.

"Water supply plan" means a document developed in compliance with 9VAC25-780.

9VAC25-210-340. Application requirements for surface water withdrawals.

A. Persons proposing to initiate a new or expanded surface water withdrawal not excluded from requirements of this chapter by 9VAC25-210-310, proposing to reapply for a current permitted withdrawal, or a Federal Energy Regulatory Commission (FERC) license or relicense associated with a surface water withdrawal, shall apply for a VWP permit.

B. In addition to informational requirements of 9VAC25-210-80 B and if applicable, 9VAC25-210-80 C, applications for surface water withdrawals or a FERC license or relicense associated with a surface water withdrawal shall include:

1. As part of identifying the project purpose, a narrative describing the water supply issues that form the basis of the proposed project purpose.

2. The drainage area, the average annual flow and the median monthly flows at the withdrawal point, and historical low flows, if available.

3. The average daily withdrawal; the maximum daily, monthly, annual, and instantaneous withdrawals; and information on the variability of the demand by season. If the project has multiple intake structures, provide for each individual intake structure and the cumulative volumes for the entire surface water withdrawal system.

4. The monthly consumptive use volume in million gallons and the average daily return flow in million gallons per day of the proposed project and the location of the return flow, including the latitude and longitude and the drainage area in square miles at the discharge point.

5. Information on flow dependent beneficial uses along the affected stream reach. For projects that propose a transfer of water resources from a major river basin to another major river basin, this analysis should include both the source and receiving basins.

a. Evaluation of the flow dependent instream and offstream beneficial uses. Instream beneficial uses include, but are not limited to, the protection of fish and wildlife habitat, maintenance of waste assimilation, recreation, navigation, and cultural and aesthetic values. Offstream beneficial uses include, but are not limited to, domestic (including public water supply), agricultural, electric power generation, and commercial and industrial uses.

b. The aquatic life, including species and habitat requirements.

c. How the proposed withdrawal will alter flows.

6. Information on the proposed use of and need for the surface water and information on how demand for surface water was determined (e.g., per capita use, population growth rates, new uses, changes to service areas, and if applicable, acreage irrigated and evapotranspiration effects). If during the water supply planning process, the need for the withdrawal was established, the applicant may submit the planning process information, provided that the submittal addresses all requirements of 9VAC25-210-360. The department shall deem such a submittal as meeting the requirements of this subsection. For surface water withdrawals for public water supply, see also 9VAC25-780-100 and 9VAC25-780-130.

7. Information describing the intake structure, to include intake screen mesh size and intake velocity.

8. For withdrawals proposed from an impoundment, the following:

a. Description of the flow or release control structures, including the minimum rate of flow, in cubic feet per second, size and capacity of the structure, and the mechanism to control the release.

b. Surface area in acres, maximum depth in feet, normal pool elevation, total storage capacity, and unusable storage volume in acre-feet.

c. The stage-storage relationship. For example, the volume of water in the impoundment at varying stages of water depth.

9. Whether the proposed surface water withdrawal is addressed in the water supply plan that covers the area in which the withdrawal is proposed to be located. If the proposed withdrawal is included, provide a discussion as to how the proposed withdrawal is addressed in the water supply plan, specifically in terms of projected demand, analysis of alternatives, and water conservation measures. If all or a portion of the withdrawn water will be transferred to an area not covered by the plan, the discussion shall also include the water supply plan for the area of the receiving watershed.

10. An alternatives analysis for the proposed surface water withdrawal, including at a minimum, the criteria in 9VAC25-210-360.

11. For new or expanded surface water withdrawals proposing to withdraw 90 million gallons a month or greater, a summary of the steps taken to seek public input as required by 9VAC25-210-320 and an identification of the issues raised during the course of the public information meeting process.

12. For new or expanded surface water withdrawals that involve a transfer of water between major river basins that may impact a river basin in another state, a plan describing procedures to notify potentially affected persons, both in and outside of Virginia, of the proposed project.

13. For surface water withdrawals, other than for public water supply, information to demonstrate that alternate sources of water supply are available to support the operation of the facility during times of reduced instream flow.

14. For surface water withdrawals for public water supply, a water auditing plan for an annual water loss audit in accordance with the American Water Works Association (AWWA) methodology for water loss auditing using the most recent version of the AWWA Water Audit Software or another methodology approved by the department that estimates water loss.

a. A water loss audit using an approved methodology shall be conducted annually. The requirement to conduct an annual water loss audit shall begin upon permit issuance. By the end of the first year of the permit term, the permittee shall submit documentation to the department that the water loss audit has been initiated. This documentation shall include activities completed during the first year of the permit term.

b. The applicant shall report the results of the annual water loss audits in a report submitted at a minimum of every three years.

15. For surface water withdrawals for public water supply, a leak detection and repair plan shall be submitted. The leak detection and repair plan shall indicate how its implementation will be informed by the results of the annual water loss audit process and shall be updated during each new permit term. The plan shall include:

a. A description of how the water loss audit results are expected to inform prioritization of actions to address water loss;

b. Where practicable, a process for the identification of equipment needs to quantify and reduce water loss;

c. Where practicable, a schedule for inspection of equipment and distribution systems for actual water losses; and

d. In the report required by subdivision B 14 b of this section, a description of the plan's effectiveness in addressing water loss, including revisions to those elements of the leak detection and repair plan that can be improved over the short [ term ] and long term.

16. For surface water withdrawals for commercial and industrial users, a water auditing plan for a water loss audit to be conducted beginning in the first three years of the permit term. The plan shall include a description of the methodology used to determine the water loss for the operation and the quantity of water used throughout the facility.

a. A water audit using this methodology shall be conducted once every three years. The requirement to conduct a water loss audit shall begin upon permit issuance. The permittee shall submit documentation to include activities completed during the first three years of the permit term.

b. The applicant shall conduct a water loss audit and report the results of the water loss audits in a report submitted every three years.

17. For surface water withdrawals for commercial and industrial users, a leak detection and repair plan shall be submitted. The leak detection and repair plan shall indicate how its implementation will be informed by the results of the water loss audit process and shall be updated during each new permit term. The plan shall include:

a. A description of how the water audit results are expected to inform prioritization of actions to address water loss;

b. Where practicable, a process for the identification of equipment needs to quantify and reduce water loss;

c. Where practicable, a schedule for inspection of equipment and piping systems for actual water losses; and

d. In the report required by subdivision B 16 b of this section, a description of the leak detection and repair plan's effectiveness in addressing water loss, including revisions to those elements of the leak detection and repair plan that can be improved over the short [ term ] and long term.

18. For surface water withdrawals for agricultural users, a water auditing plan for an annual water loss audit that shall be conducted annually or periodically based on agricultural management plans or irrigation management plans, including the anticipated crop rotation schedule or livestock growth stages. The water auditing plan shall include an estimate of water loss for the agricultural operation and a description of the methodology used to determine the quantity of water used throughout the agricultural operation.

a. A water audit using this methodology shall be conducted. The requirement to conduct a water loss audit shall begin upon permit issuance. By the end of the first year of the permit term, the permittee shall submit documentation to the department that the water loss audit has been initiated. This documentation shall include activities completed during the first year of the permit term.

b. The applicant shall report the results of the water loss audit in a report submitted at a minimum every three years.

19. For surface water withdrawals for agricultural users, a leak detection and repair plan shall be submitted. The leak detection and repair plan shall indicate how its implementation will be informed by the results of the water loss audit process and shall be updated during each new permit term. The plan shall include:

a. A description of how the water audit results are expected to inform prioritization of actions to address water loss;

b. Where practicable, a schedule for inspection of equipment and distribution systems for actual water losses; and

c. In the report required by subdivision B 18 b of this section, a description of the leak detection and repair plan's effectiveness in addressing water loss, including revisions to those elements of the leak detection and repair plan that can be improved over the short [ term ] and long term.

C. Applications for an Emergency Virginia Water Protection Permit.

1. Applications for an Emergency Virginia Water Protection Permit to address a public water supply emergency shall include the information noted in subdivisions 1 a through 1 o of this subsection. The JPA may be used for emergency application purposes, provided that all of the information in subdivisions 1 a through 1 o of this subsection is included:

a. The applicant's legal name, mailing address, telephone number, and if applicable, fax number and electronic mail email address;

b. If different from applicant, name, mailing address, telephone number, and if applicable, fax number and electronic mail email address of property owner;

c. If applicable, authorized agent's name, mailing address, telephone number, and if applicable, fax number and electronic mail email address;

d. Name of water body or water bodies, or receiving waters, as applicable;

e. Name of the city or county where the project occurs;

f. Signed and dated signature page (electronic submittals containing the original signature page, such as that contained in a scanned document file are acceptable);

g. Permit application fee in accordance with 9VAC25-20;

h. The drainage area, the average annual flow and the median monthly flows at the withdrawal point, and historical low flows, if available;

i. Information on the aquatic life along the affected stream reach, including species and habitat requirements;

j. Recent and current water use, including monthly water use in the previous calendar year and weekly water use in the previous six months prior to the application. The application shall identify the sources of such water and also identify any water purchased from other water suppliers;

k. A description of the severity of the public water supply emergency, including (i) for reservoirs, an estimate of days of remaining supply at current rates of use and replenishment; (ii) for wells, current production; and (iii) for intakes, current streamflow;

l. A description of mandatory water conservation measures taken or imposed by the applicant and the dates when the measures were implemented; for the purposes of obtaining an Emergency Virginia Water Protection Permit, mandatory water conservation measures shall include, but not be limited to, the prohibition of lawn and landscape watering, vehicle washing, watering of recreation fields, refilling of swimming pools, and washing of paved surfaces;

m. An estimate of water savings realized by implementing mandatory water conservation measures;

n. Documentation that the applicant has exhausted all management actions that would minimize the threat to public welfare, safety, and health and will avoid the need to obtain an emergency permit, and that are consistent with existing permit limitations; and

o. Any other information that demonstrates that the condition is a substantial threat to public health or safety.

2. Within 14 days after the issuance of an Emergency Virginia Water Protection Permit, the permit holder shall apply for a VWP permit under the other provisions of this chapter.

9VAC25-610-10. Definitions.

Unless a different meaning is required by the context, the following terms as used in this chapter shall have the following meanings:

"Act" means the Ground Water Management Act of 1992, Chapter 25 (§ 62.1-254 et seq.) of Title 62.1 of the Code of Virginia.

"Adverse impact" means reductions in groundwater levels or changes in groundwater quality that limit the ability of any existing groundwater user lawfully withdrawing or authorized to withdraw groundwater at the time of permit or special exception issuance to continue to withdraw the quantity and quality of groundwater required by the existing use. Existing groundwater users include all those persons who have been granted a groundwater withdrawal permit subject to this chapter and all other persons who are excluded from permit requirements by 9VAC25-610-50.

"Agricultural use" means utilizing groundwater for the purpose of agricultural, silvicultural, horticultural, or aquacultural operations. Agricultural use includes withdrawals for turf farm operations, but does not include withdrawals for landscaping activities or turf installment and maintenance associated with landscaping activities.

"Applicant" means a person filing an application to initiate or enlarge a groundwater withdrawal in a groundwater management area.

"Area of impact" means the areal extent of each aquifer where more than one foot of drawdown is predicted to occur due to a proposed withdrawal.

"Beneficial use" includes domestic (including public water supply), agricultural, commercial, and industrial uses.

"Board" means the State Water Control Board. When used outside the context of the promulgation of regulations, including regulations to establish general permits, "board" means the Department of Environmental Quality.

"Consumptive use" means the withdrawal of groundwater, without recycle of said waters to their source of origin.

"Controversial permit" means a water permitting action for which a public hearing has been granted pursuant to 9VAC25-610-270 and 9VAC25-610-275.

"Department" means the Department of Environmental Quality.

"Director" means the Director of the Department of Environmental Quality.

"Draft permit" means a prepared document indicating the department's tentative decision relative to a permit action.

"General permit" means a groundwater withdrawal permit authorizing the withdrawal of groundwater in a groundwater management area under specified conditions, including the size of the withdrawal or the aquifer or confining unit from which the withdrawal is to be made.

"Geophysical investigation" means any hydrogeologic evaluation to define the hydrogeologic framework of an area or determine the hydrogeologic properties of any aquifer or confining unit to the extent that withdrawals associated with such investigations do not result in unmitigated adverse impacts to existing groundwater users. Geophysical investigations include pump tests and aquifer tests.

"Groundwater" means any water, except capillary moisture, beneath the land surface in the zone of saturation or beneath the bed of any stream, lake, reservoir, or other body of surface water wholly or partially within the boundaries of this Commonwealth, whatever the subsurface geologic structure in which such water stands, flows, percolates, or otherwise occurs.

"Human consumption" means the use of water to support human survival and health, including drinking, bathing, showering, cooking, dishwashing, and maintaining hygiene.

"Instream beneficial uses" means uses including the protection of fish and wildlife resources and habitat, maintenance of waste assimilation, recreation, navigation, and cultural and aesthetic values. The preservation of instream flows for purposes of the protection of navigation, maintenance of waste assimilation capacity, the protection of fish and wildlife resources and habitat, recreation, and cultural and aesthetic values is an instream beneficial use of Virginia's waters.

"Mitigate" means to take actions necessary to assure ensure that all existing groundwater users at the time of issuance of a permit or special exception who experience adverse impacts continue to have access to the amount and quality of groundwater needed for existing uses.

"Permit" means a groundwater withdrawal permit issued under the Ground Water Management Act of 1992 permitting the withdrawal of a specified quantity of groundwater under specified conditions in a groundwater management area.

"Permittee" means a person that currently has an effective groundwater withdrawal permit issued under the Ground Water Act of 1992.

"Person" means any and all persons, including individuals, firms, partnerships, associations, public or private institutions, municipalities or political subdivisions, governmental agencies, or private or public corporations organized under the laws of this Commonwealth or any other state or country.

"Practicable" means available and capable of being done after taking into consideration cost, existing technology, and logistics in light of overall project purposes.

"Private well" means, as defined in § 32.1-176.3 of the Code of Virginia, any water well constructed for a person on land that is owned or leased by that person and is usually intended for household, groundwater source heat pump, agricultural use, industrial use, or other nonpublic water well.

"Public hearing" means a fact finding fact-finding proceeding held to afford interested persons an opportunity to submit factual data, views, and comments to the department.

"Public water supply" means a system that provides water for human consumption through pipes or other constructed conveyances to at least 15 service connections or serves an average of at least 25 people for at least 60 days a year. A public water supply may be publicly or privately owned.

"Salt water intrusion" means the encroachment of saline waters in any aquifer that creates adverse impacts to existing groundwater users or is counter to the public interest.

"Special exception" means a document issued by the department for withdrawal of groundwater in unusual situations where requiring the user to obtain a groundwater withdrawal permit would be contrary to the purpose of the Ground Water Management Act of 1992. Special exceptions allow the withdrawal of a specified quantity of groundwater under specified conditions in a groundwater management area.

"Supplemental drought relief well" means a well permitted to withdraw a specified amount of groundwater to meet human consumption needs during declared drought conditions after mandatory water use restrictions have been implemented.

"Surface water" means all state waters that are not groundwater as groundwater is defined in § 62.1-255 of the Code of Virginia.

"Surface water and groundwater conjunctive use system" means an integrated water supply system wherein surface water is the primary source and groundwater is a supplemental source that is used to augment the surface water source when the surface water source is not able to produce the amount of water necessary to support the annual water demands of the system.

"Surficial aquifer" means the upper surface of a zone of saturation, where the body of groundwater is not confined by an overlying impermeable zone.

"Water loss" means the difference between the estimated or measured volume of water withdrawn and the estimated or measured volume applied to the beneficial use.

"Water loss audit" means the review of records and data that traces the flow of water from its withdrawal through distribution and application to the beneficial use.

"Water well systems provider" means any individual who is certified by the Board for Contractors in accordance with § 54.1-1128 et seq. of the Code of Virginia and who is engaged in drilling, installation, maintenance, or repair of water wells, water well pumps, ground source heat exchangers, and other equipment associated with the construction, removal, or repair of water wells, water well systems, and ground source heat pump exchangers to the point of connection to the ground source heat pump.

"Well" means any artificial opening or artificially altered natural opening, however made, by which groundwater is sought or through which groundwater flows under natural pressure or is intended to be withdrawn.

"Withdrawal system" means (i) one or more wells or withdrawal points located on the same or contiguous properties under common ownership for which the withdrawal is applied to the same beneficial use or (ii) two or more connected wells or withdrawal points that are under common ownership but are not necessarily located on contiguous properties.

9VAC25-610-100. Water conservation and management plans.

A. Any application to initiate a new withdrawal or expand an existing withdrawal in any groundwater management area or the reapplication at the end of a permit cycle for all permits shall require a water conservation and management plan before the application or reapplication is considered complete. The department shall review all water conservation and management plans and assure ensure that such plans contain all elements required in subsection B of this section. The approved plan shall become an enforceable part of the approved permit.

B. A water conservation and management plan is an operational plan to be referenced and implemented by the permittee. Water conservation and management plans shall be consistent with local and regional water supply plans in the applicant's geographic area developed as required by 9VAC25-780. The water conservation and management plan shall be specific to the type of water use and include the following:

1. For municipal and nonmunicipal public water supplies a public water supply, the required water conservation and management plan shall include:

a. Where practicable, the plan should require use of water-saving equipment and processes for all water users including technological, procedural, or programmatic improvements to the facilities and processes to decrease the amount of water withdrawn or to decrease water demand. The goal of these requirements is to assure the most efficient use of groundwater. Information on the water-saving alternatives examined and the water savings associated with the alternatives shall be provided. Water conservation and management plans shall discuss high volume water consumption by users on the system and where conservation measures have previously been implemented and shall be applied. Also, where appropriate, the use of water-saving fixtures in new and renovated plumbing as provided in the Uniform Statewide Building Code (13VAC5-63) shall be identified in the plan; A water auditing plan for an annual water loss audit in accordance with the American Water Works Association (AWWA) methodology for water loss auditing, using the most recent version of the AWWA Water Audit Software or another methodology approved by the department that estimates water loss.

(1) A water loss audit using an approved methodology shall be conducted annually. The requirement to conduct an annual water loss audit shall begin upon permit issuance. By the end of the first year of the permit term, the permittee shall submit documentation to the department that the water loss audit has been initiated. This documentation shall include activities completed during the first year of the permit term.

(2) The applicant shall report the results of the annual water loss audits in a report submitted at a minimum every three years. The report shall also include any revisions to the water auditing plan over the short [ term ] and long term.

b. A water loss reduction program, which defines the applicant's leak detection and repair program. The water loss reduction program plan shall include requirements for an audit of the total amount of groundwater used in the distribution system and operational processes during the first two years of the permit cycle. Implementation of a be submitted as a component of the water conservation and management plan. The leak detection and repair program plan shall be required within one year of the date the permit is issued. The program shall include a schedule for inspection of equipment and piping for leaks; indicate how its implementation will be informed by the results of the annual water loss audit process and shall be updated during each new permit term. The plan shall include:

(1) A description of how the water loss audit results are expected to inform prioritization of actions to address water loss;

(2) Where practicable, a process for the identification of equipment needs to quantify and reduce water loss;

(3) Where practicable, a schedule for inspection of equipment and distribution systems for actual water losses; and

(4) In the report required by subdivision 1 a (2) of this subsection, a description of the leak detection and repair plan's effectiveness in addressing water loss, including revisions to those elements of the leak detection and repair plan that can be improved over the short [ term ] and long term.

c. Other components of a water conservation and management plan include:

(1) A water use education program that contains requirements for the education of water users and training of employees controlling water consuming processes to assure ensure that water conservation principles are well known by the users of the resource. The program shall include a schedule for information distribution and the type of materials used;

d. (2) An evaluation of water reuse options and assurances that water shall be reused in all instances where reuse is practicable. Potential for expansion of the existing reuse practices or adoption of additional reuse practices shall also be included; and

e. (3) Where practicable, a requirement for the use of water-saving equipment and processes for all water users, including technological, procedural, or programmatic improvements to the facilities and processes to decrease the amount of water withdrawn or to decrease water demand. Information on the water-saving alternatives examined and the water savings associated with the alternatives shall be provided. Water conservation and management plans shall discuss high volume water consumption by users on the system and where conservation measures have previously been implemented and shall be applied. Where appropriate, the use of water-saving fixtures in new and renovated plumbing, as provided in the Virginia Uniform Statewide Building Code (13VAC5-63), shall also be identified in the plan; and

(4) Requirements for mandatory water use reductions during water shortage emergencies declared by the local governing body or water authority consistent with §§ 15.2-923 and 15.2-924 of the Code of Virginia. This shall include, where appropriate, ordinances in municipal systems prohibiting the waste of water generally and requirements providing for mandatory water use restrictions in accordance with drought response and contingency ordinances implemented to comply with 9VAC25-780-120 during water shortage emergencies. The water conservation and management plan shall also contain requirements for mandatory water use restrictions during water shortage emergencies that restricts or prohibits all nonessential uses such as lawn watering, car washing, and similar nonessential residential, industrial, and commercial uses for the duration of the water shortage emergency. Penalties for failure to comply with mandatory water use restrictions shall be included in municipal system plans.

2. For nonpublic water supply applicants - a commercial and industrial users user, the required water conservation and management plan shall include:

a. Where applicable, the plan should require use of water-saving equipment and processes for all water users including technological, procedural, or programmatic improvements to the facilities and processes to decrease the amount of water withdrawn or to decrease water demand. The goal of these requirements is to assure the most efficient use of groundwater. Information on the water-saving alternatives examined and the water savings associated with the alternatives shall be provided. Also, where appropriate, the use of water-saving fixtures in new and renovated plumbing as provided in the Uniform Statewide Building Code (13VAC5-63) shall be identified in the plan; A water auditing plan for a water loss audit to be conducted beginning in the first three years of the permit term. The plan shall include a description of the methodology used to estimate the water loss for the operation and the quantity of water used throughout the facility.

(1) A water loss audit using this methodology shall be conducted once every three years. The requirement to conduct a water loss audit shall begin upon permit issuance. Documentation shall include activities completed during the first three years of the permit term.

(2) The applicant shall conduct a water loss audit and report the results of the water loss audit in a report submitted every three years.

b. A water loss reduction program, which defines the applicant's leak detection and repair program. The water loss reduction program plan shall include requirements for an audit of the total amount of groundwater used in the distribution system and operational processes during the first two years of the permit cycle. Implementation of a be submitted as a component of the water conservation and management plan. The leak detection and repair program shall be required within one year of the date the permit is issued plan shall indicate how its implementation will be informed by the results of the water loss audit process and shall be updated during each new permit term. The program plan shall include a schedule for inspection of equipment and piping for leaks;:

(1) A description of how the water loss audit results are expected to inform prioritization of actions to address water loss;

(2) Where practicable, a process for the identification of equipment needs to quantify and reduce water loss;

(3) Where practicable, a schedule for inspection of equipment and piping systems for actual water losses;

(4) Where practicable, a requirement for use of water-saving equipment and processes, including technological, procedural, or programmatic improvements to the facilities and processes to decrease the amount of water withdrawn or to decrease water demand. The goal of these requirements is to ensure the most efficient use of groundwater. Information on the water-saving alternatives examined and the water savings associated with the alternatives shall be provided. Water conservation and management plans shall discuss high volume water processes in the facility and where conservation measures have previously been implemented and shall be applied. Where appropriate, the use of water-saving fixtures in new and renovated plumbing, as provided in the Virginia Uniform Statewide Building Code, shall also be identified in the plan; and

(5) In the report required by subdivision 2 a (2) of this subsection, a description of the plan's effectiveness in addressing water loss, including revisions to those elements of the water conservation and management plan that can be improved over the short [ term ] and long term.

c. Other components of a water conservation and management plan include:

(1) A water use education program that contains requirements for the education of water users and training of employees controlling water consuming processes to assure ensure that water conservation principles are well known by the users of the resource. The program shall include a schedule for information distribution and the type of materials used;

d. (2) An evaluation of water reuse options and assurances that water shall be reused in all instances where reuse is practicable. Potential for expansion of the existing reuse practices or adoption of additional reuse practices shall also be included; and

e. (3) Where practicable, actions to encourage or provide incentives for the use of water-saving fixtures in new and renovated plumbing, as provided under the Virginia Uniform Statewide Building Code, shall be identified in the plan; and

(4) Requirements for complying with mandatory water use reductions during water shortage emergencies declared by the local governing body or water authority in accordance with §§ 15.2-923 and 15.2-924 of the Code of Virginia. This shall include, where appropriate, ordinances prohibiting the waste of water generally and requirements providing for mandatory water use restrictions in accordance with drought response and contingency ordinances implemented to comply with 9VAC25-780-120 during water shortage emergencies. The water conservation and management plan shall also contain requirements for mandatory water use restrictions during water shortage emergencies that restricts or prohibits all nonessential uses such as lawn watering, car washing, and similar nonessential industrial and commercial uses for the duration of the water shortage emergency.

3. For nonpublic water supply applicants - an agricultural users user, the required water conservation and management plan shall include:

a. Requirements for the use of water-saving plumbing and processes to decrease the amount of water withdrawn or to decrease water demand. Plans submitted for the use of groundwater for irrigation shall identify the specific type of irrigation system that will be utilized, the efficiency rating of the irrigation system in comparison to less efficient systems, the irrigation schedule used to minimize water demand, and the crop watering requirements. Multiple types of irrigation methods may be addressed in the plan. For livestock watering operations, plans shall include livestock watering requirements (per head) and processes to minimize waste of water. These requirements shall assure that the most practicable use is made of groundwater. If these options are not implemented in the plan, information on the water-saving alternatives examined and the water savings associated with the alternatives shall be provided; A water auditing plan for an annual water loss audit that shall be conducted annually or periodically based on agricultural management plans or irrigation management plans, including the anticipated crop rotation schedule or livestock growth stages. The water auditing plan shall include an estimate of water loss for the agricultural operation and a description of the methodology used to determine the quantity of water used throughout the agricultural operation.

(1) A water loss audit using this methodology shall be conducted. The requirement to conduct a water loss audit shall begin upon permit issuance. By the end of the first year of the permit term, the permittee shall submit documentation to the department that the water loss audit has been initiated. This documentation shall include activities completed during the first year of the permit term.

(2) The applicant shall report the results of the water loss audit in a report submitted at a minimum every three years.

b. A water loss reduction program, which defines the applicant's leak detection and repair program. The water loss reduction program plan shall include requirements for an audit of the total amount of groundwater used in the distribution system and operational processes during the first two years of the permit cycle. Implementation of a be submitted as a component of the water conservation and management plan. The leak detection and repair program plan shall be required within one year of the date the permit is issued. The program shall include a schedule for inspection of equipment and piping for leaks;:

(1) A description of how the water loss audit results are expected to inform prioritization of actions to address water loss;

(2) For plans submitted for the use of groundwater for irrigation, identification of the specific type of irrigation system that will be utilized, the efficiency rating of the irrigation system in comparison to less efficient systems, the irrigation management methods used to minimize water demand, and the anticipated crop watering requirements. Multiple types of irrigation methods may be addressed in the plan. For livestock watering operations, plans shall include livestock watering requirements (per head) and processes to minimize waste of water. If these options are not implemented in the plan, information on the water-saving alternatives examined and the water savings associated with the alternatives shall be provided;

(3) Where practicable, a schedule for inspection of equipment and distribution systems for water loss;

(4) Where practicable, the use of water-saving equipment and processes, including technological, procedural, or programmatic improvements to the facilities and processes to decrease the amount of water withdrawn or to decrease water loss. The goal of these requirements is to ensure the most efficient use of groundwater. Information on the water-saving alternatives examined and the water savings associated with the alternatives should be provided. Water conservation and management plans shall discuss high volume water consumption by processes in the agricultural operation and where conservation measures have previously been implemented and shall be applied. Where practicable, the use of water-saving fixtures in new and renovated plumbing, as provided in the Virginia Uniform Statewide Building Code, shall also be identified in the plan; and

(5) In the report required by subdivision 3 a (2) of this subsection, a description of the leak detection and repair plan's effectiveness in addressing water loss, including revisions to those elements of the leak detection and repair plan that can be improved over the short [ term ] and long term.

c. Other components of a water conservation and management plan include:

(1) A water use education program that contains requirements for the training of employees controlling water consuming processes to assure ensure that water conservation principles are well known by the users of the resource. The program shall include a schedule for training employees. This requirement may be met through training employees on water use requirements contained in irrigation management plans or livestock management plans;

d. (2) An evaluation of potential water reuse options and assurances that water shall be reused in all instances where reuse is practicable and not prohibited by other regulatory programs;. Potential for expansion of the existing reuse practices or adoption of additional reuse practices shall also be included; and

e. (3) Requirements for mandatory water use reductions during water shortage emergencies and compliance with ordinances prohibiting the waste of water generally. This shall include requirements providing for mandatory water use restrictions in accordance with drought response and contingency ordinances implemented to comply with 9VAC25-780-120 during water shortage emergencies. f.; and

(4) The permittee may submit portions of Agricultural Management Plans or Irrigation Management Plans developed to comply with requirements of federal or state laws, regulations, or guidelines to demonstrate the requirements of subdivisions B 3 a through d B 3 c (3) of this section are being achieved.

TITLE 9. ENVIRONMENT

STATE WATER CONTROL BOARD

Final Regulation

Titles of Regulations: 9VAC25-210. Virginia Water Protection Permit Program Regulation (amending 9VAC25-210-300, 9VAC25-210-340).

9VAC25-610. Groundwater Withdrawal Regulations (amending 9VAC25-610-10, 9VAC25-610-100).

Statutory Authority: § 62.1-44.15 of the Code of Virginia; § 401 of the Clean Water Act (33 USC § 1251 et seq.).

Effective Date: August 13, 2025.

Agency Contact: Eric Seavey, Department of Environmental Quality, 1111 East Main Street, Suite 1400, P.O. Box 1105, Richmond, VA 23218, telephone (804) 754-6250, or email eric.seavey@deq.virginia.gov.

Summary:

Pursuant to Chapter 100 of the 2021 Acts of Assembly, Special Session I, and as required by the third enactment clause of Chapter 100 to make the first enactment clause of Chapter 100 effective, the amendments require that any application for a permit to withdraw surface water as provided in 9VAC25-210 or groundwater as provided in 9VAC25-610 include (i) a water auditing plan and (ii) a leak detection plan.

Summary of Public Comments and Agency's Response: A summary of comments made by the public and the agency's response may be obtained from the promulgating agency or viewed at the office of the Registrar of Regulations.

9VAC25-210-300. Definitions for surface water withdrawals.

The following words and terms when used in this part shall have the following meanings:

"Affected stream reach" means the portion of a surface water body beginning at the location of a withdrawal and ending at a point where effects of the withdrawal are not reasonably expected to adversely affect beneficial uses.

"Agricultural surface water withdrawal" means a withdrawal of surface water in Virginia or from the Potomac River for the purpose of agricultural, silvicultural, horticultural, or aquacultural operations. Agricultural surface water withdrawals include withdrawals for turf farm operations, but do not include withdrawals for landscaping activities, or turf installment and maintenance associated with landscaping activities.

"Consumptive use" means any use of water withdrawn from a surface water other than a nonconsumptive use.

"Drought" means the declaration of a drought stage by the Virginia Drought Coordinator or the Governor of Virginia for a particular area or locality within Virginia. Drought stage declarations include watch, warning, and emergency, depending upon severity, as defined by the Virginia Drought Assessment and Response Plan dated March 28, 2003.

"Drought of record" means the time period during which the most severe drought conditions occurred for a particular area or location, as indicated by the available hydrologic and meteorologic data.

"Emergency Virginia Water Protection Permit" means a Virginia Water Protection Permit issued pursuant to § 62.1-44.15:22 C of the Code of Virginia authorizing a new or increased surface water withdrawal to address insufficient public drinking water supplies that are caused by a drought and may result in a substantial threat to human health or public safety.

"Human consumption" means the use of water to support human survival and health, including drinking, bathing, showering, cooking, dishwashing, and maintaining hygiene.

"Instream flow" means the existing volume of water flowing in a stream or water body, including any seasonal variations of water levels and flow.

"Intake structure" means any portion of a surface water withdrawal system used to withdraw surface water that is located within the surface water, such as, but not limited to, a pipe, culvert, hose, tube, or screen.

"Major river basin" means the Potomac-Shenandoah River Basin, the Rappahannock River Basin, the York River Basin, the James River Basin, the Chowan River Basin, the Roanoke River Basin, the New River Basin, or the Tennessee-Big Sandy River Basin.

"Nonconsumptive use" means the use of water withdrawn from a surface water in such a manner that it is returned to the surface water without substantial diminution in quantity at or near the point from which it was taken and would not result in or exacerbate low flow conditions.

"Potomac River Low Flow Allocation Agreement" means the agreement among the United States of America, the State of Maryland, the Commonwealth of Virginia, the District of Columbia, the Washington Suburban Sanitation Commission, and the Fairfax County Water Authority dated January 11, 1978, consented to by the United States Congress in § 181 of the Water Resources Development Act of 1976, Public Law 94-587, as modified on April 22, 1986.

"Public water supply" means a withdrawal of surface water in Virginia or from the Potomac River for the production of drinking water, distributed to the general public for the purpose of, but not limited to, domestic use.

"Public water supply emergency" means a substantial threat to public health or safety due to insufficient public drinking water supplies caused by drought.

"Section for Cooperative Water Supply Operations on the Potomac" means a section of the Interstate Commission on the Potomac River Basin designated by the Water Supply Coordination Agreement as responsible for coordination of water resources during times of low flow in the Potomac River.

"Surface water withdrawal" means a removal or diversion of surface water in Virginia or from the Potomac River for consumptive or nonconsumptive use thereby altering the instream flow or hydrologic regime of the surface water. Projects that do not alter the instream flow or that alter the instream flow but whose sole purpose is flood control or stormwater management are not included in this definition.

"Surface water withdrawal system" means any device or combination of devices used to withdraw surface water such as, but not limited to, a machine, pump, culvert, hose, tube, screen, or fabricated concrete or metal structure.

"Variance" means a mechanism that allows temporary waiver of the generally applicable withdrawal limitation requirements or instream flow conditions of a VWP permit during a drought.

"Water loss" means the difference between the estimated or measured volume of water withdrawn and the estimated or measured volume applied to the beneficial use.

"Water loss audit" means the review of records and data that traces the flow of water from its withdrawal through distribution and application to the beneficial use.

"Water Supply Coordination Agreement" means the agreement among the United States of America, the Fairfax County Water Authority, the Washington Suburban Sanitary Commission, the District of Columbia, and the Interstate Commission on the Potomac River Basin, dated July 22, 1982, which establishes agreement among the suppliers to operate their respective water supply systems in a coordinated manner and which outlines operating rules and procedures for reducing impacts of severe droughts in the Potomac River Basin.

"Water supply plan" means a document developed in compliance with 9VAC25-780.

9VAC25-210-340. Application requirements for surface water withdrawals.

A. Persons proposing to initiate a new or expanded surface water withdrawal not excluded from requirements of this chapter by 9VAC25-210-310, proposing to reapply for a current permitted withdrawal, or a Federal Energy Regulatory Commission (FERC) license or relicense associated with a surface water withdrawal, shall apply for a VWP permit.

B. In addition to informational requirements of 9VAC25-210-80 B and if applicable, 9VAC25-210-80 C, applications for surface water withdrawals or a FERC license or relicense associated with a surface water withdrawal shall include:

1. As part of identifying the project purpose, a narrative describing the water supply issues that form the basis of the proposed project purpose.

2. The drainage area, the average annual flow and the median monthly flows at the withdrawal point, and historical low flows, if available.

3. The average daily withdrawal; the maximum daily, monthly, annual, and instantaneous withdrawals; and information on the variability of the demand by season. If the project has multiple intake structures, provide for each individual intake structure and the cumulative volumes for the entire surface water withdrawal system.

4. The monthly consumptive use volume in million gallons and the average daily return flow in million gallons per day of the proposed project and the location of the return flow, including the latitude and longitude and the drainage area in square miles at the discharge point.

5. Information on flow dependent beneficial uses along the affected stream reach. For projects that propose a transfer of water resources from a major river basin to another major river basin, this analysis should include both the source and receiving basins.

a. Evaluation of the flow dependent instream and offstream beneficial uses. Instream beneficial uses include, but are not limited to, the protection of fish and wildlife habitat, maintenance of waste assimilation, recreation, navigation, and cultural and aesthetic values. Offstream beneficial uses include, but are not limited to, domestic (including public water supply), agricultural, electric power generation, and commercial and industrial uses.

b. The aquatic life, including species and habitat requirements.

c. How the proposed withdrawal will alter flows.

6. Information on the proposed use of and need for the surface water and information on how demand for surface water was determined (e.g., per capita use, population growth rates, new uses, changes to service areas, and if applicable, acreage irrigated and evapotranspiration effects). If during the water supply planning process, the need for the withdrawal was established, the applicant may submit the planning process information, provided that the submittal addresses all requirements of 9VAC25-210-360. The department shall deem such a submittal as meeting the requirements of this subsection. For surface water withdrawals for public water supply, see also 9VAC25-780-100 and 9VAC25-780-130.

7. Information describing the intake structure, to include intake screen mesh size and intake velocity.

8. For withdrawals proposed from an impoundment, the following:

a. Description of the flow or release control structures, including the minimum rate of flow, in cubic feet per second, size and capacity of the structure, and the mechanism to control the release.

b. Surface area in acres, maximum depth in feet, normal pool elevation, total storage capacity, and unusable storage volume in acre-feet.

c. The stage-storage relationship. For example, the volume of water in the impoundment at varying stages of water depth.

9. Whether the proposed surface water withdrawal is addressed in the water supply plan that covers the area in which the withdrawal is proposed to be located. If the proposed withdrawal is included, provide a discussion as to how the proposed withdrawal is addressed in the water supply plan, specifically in terms of projected demand, analysis of alternatives, and water conservation measures. If all or a portion of the withdrawn water will be transferred to an area not covered by the plan, the discussion shall also include the water supply plan for the area of the receiving watershed.

10. An alternatives analysis for the proposed surface water withdrawal, including at a minimum, the criteria in 9VAC25-210-360.

11. For new or expanded surface water withdrawals proposing to withdraw 90 million gallons a month or greater, a summary of the steps taken to seek public input as required by 9VAC25-210-320 and an identification of the issues raised during the course of the public information meeting process.

12. For new or expanded surface water withdrawals that involve a transfer of water between major river basins that may impact a river basin in another state, a plan describing procedures to notify potentially affected persons, both in and outside of Virginia, of the proposed project.

13. For surface water withdrawals, other than for public water supply, information to demonstrate that alternate sources of water supply are available to support the operation of the facility during times of reduced instream flow.

14. For surface water withdrawals for public water supply, a water auditing plan for an annual water loss audit in accordance with the American Water Works Association (AWWA) methodology for water loss auditing using the most recent version of the AWWA Water Audit Software or another methodology approved by the department that estimates water loss.

a. A water loss audit using an approved methodology shall be conducted annually. The requirement to conduct an annual water loss audit shall begin upon permit issuance. By the end of the first year of the permit term, the permittee shall submit documentation to the department that the water loss audit has been initiated. This documentation shall include activities completed during the first year of the permit term.

b. The applicant shall report the results of the annual water loss audits in a report submitted at a minimum of every three years.

15. For surface water withdrawals for public water supply, a leak detection and repair plan shall be submitted. The leak detection and repair plan shall indicate how its implementation will be informed by the results of the annual water loss audit process and shall be updated during each new permit term. The plan shall include:

a. A description of how the water loss audit results are expected to inform prioritization of actions to address water loss;

b. Where practicable, a process for the identification of equipment needs to quantify and reduce water loss;

c. Where practicable, a schedule for inspection of equipment and distribution systems for actual water losses; and

d. In the report required by subdivision B 14 b of this section, a description of the plan's effectiveness in addressing water loss, including revisions to those elements of the leak detection and repair plan that can be improved over the short [ term ] and long term.

16. For surface water withdrawals for commercial and industrial users, a water auditing plan for a water loss audit to be conducted beginning in the first three years of the permit term. The plan shall include a description of the methodology used to determine the water loss for the operation and the quantity of water used throughout the facility.

a. A water audit using this methodology shall be conducted once every three years. The requirement to conduct a water loss audit shall begin upon permit issuance. The permittee shall submit documentation to include activities completed during the first three years of the permit term.

b. The applicant shall conduct a water loss audit and report the results of the water loss audits in a report submitted every three years.

17. For surface water withdrawals for commercial and industrial users, a leak detection and repair plan shall be submitted. The leak detection and repair plan shall indicate how its implementation will be informed by the results of the water loss audit process and shall be updated during each new permit term. The plan shall include:

a. A description of how the water audit results are expected to inform prioritization of actions to address water loss;

b. Where practicable, a process for the identification of equipment needs to quantify and reduce water loss;

c. Where practicable, a schedule for inspection of equipment and piping systems for actual water losses; and

d. In the report required by subdivision B 16 b of this section, a description of the leak detection and repair plan's effectiveness in addressing water loss, including revisions to those elements of the leak detection and repair plan that can be improved over the short [ term ] and long term.

18. For surface water withdrawals for agricultural users, a water auditing plan for an annual water loss audit that shall be conducted annually or periodically based on agricultural management plans or irrigation management plans, including the anticipated crop rotation schedule or livestock growth stages. The water auditing plan shall include an estimate of water loss for the agricultural operation and a description of the methodology used to determine the quantity of water used throughout the agricultural operation.

a. A water audit using this methodology shall be conducted. The requirement to conduct a water loss audit shall begin upon permit issuance. By the end of the first year of the permit term, the permittee shall submit documentation to the department that the water loss audit has been initiated. This documentation shall include activities completed during the first year of the permit term.

b. The applicant shall report the results of the water loss audit in a report submitted at a minimum every three years.

19. For surface water withdrawals for agricultural users, a leak detection and repair plan shall be submitted. The leak detection and repair plan shall indicate how its implementation will be informed by the results of the water loss audit process and shall be updated during each new permit term. The plan shall include:

a. A description of how the water audit results are expected to inform prioritization of actions to address water loss;

b. Where practicable, a schedule for inspection of equipment and distribution systems for actual water losses; and

c. In the report required by subdivision B 18 b of this section, a description of the leak detection and repair plan's effectiveness in addressing water loss, including revisions to those elements of the leak detection and repair plan that can be improved over the short [ term ] and long term.

C. Applications for an Emergency Virginia Water Protection Permit.

1. Applications for an Emergency Virginia Water Protection Permit to address a public water supply emergency shall include the information noted in subdivisions 1 a through 1 o of this subsection. The JPA may be used for emergency application purposes, provided that all of the information in subdivisions 1 a through 1 o of this subsection is included:

a. The applicant's legal name, mailing address, telephone number, and if applicable, fax number and electronic mail email address;

b. If different from applicant, name, mailing address, telephone number, and if applicable, fax number and electronic mail email address of property owner;

c. If applicable, authorized agent's name, mailing address, telephone number, and if applicable, fax number and electronic mail email address;

d. Name of water body or water bodies, or receiving waters, as applicable;

e. Name of the city or county where the project occurs;

f. Signed and dated signature page (electronic submittals containing the original signature page, such as that contained in a scanned document file are acceptable);

g. Permit application fee in accordance with 9VAC25-20;

h. The drainage area, the average annual flow and the median monthly flows at the withdrawal point, and historical low flows, if available;

i. Information on the aquatic life along the affected stream reach, including species and habitat requirements;

j. Recent and current water use, including monthly water use in the previous calendar year and weekly water use in the previous six months prior to the application. The application shall identify the sources of such water and also identify any water purchased from other water suppliers;

k. A description of the severity of the public water supply emergency, including (i) for reservoirs, an estimate of days of remaining supply at current rates of use and replenishment; (ii) for wells, current production; and (iii) for intakes, current streamflow;

l. A description of mandatory water conservation measures taken or imposed by the applicant and the dates when the measures were implemented; for the purposes of obtaining an Emergency Virginia Water Protection Permit, mandatory water conservation measures shall include, but not be limited to, the prohibition of lawn and landscape watering, vehicle washing, watering of recreation fields, refilling of swimming pools, and washing of paved surfaces;

m. An estimate of water savings realized by implementing mandatory water conservation measures;

n. Documentation that the applicant has exhausted all management actions that would minimize the threat to public welfare, safety, and health and will avoid the need to obtain an emergency permit, and that are consistent with existing permit limitations; and

o. Any other information that demonstrates that the condition is a substantial threat to public health or safety.

2. Within 14 days after the issuance of an Emergency Virginia Water Protection Permit, the permit holder shall apply for a VWP permit under the other provisions of this chapter.

9VAC25-610-10. Definitions.

Unless a different meaning is required by the context, the following terms as used in this chapter shall have the following meanings:

"Act" means the Ground Water Management Act of 1992, Chapter 25 (§ 62.1-254 et seq.) of Title 62.1 of the Code of Virginia.

"Adverse impact" means reductions in groundwater levels or changes in groundwater quality that limit the ability of any existing groundwater user lawfully withdrawing or authorized to withdraw groundwater at the time of permit or special exception issuance to continue to withdraw the quantity and quality of groundwater required by the existing use. Existing groundwater users include all those persons who have been granted a groundwater withdrawal permit subject to this chapter and all other persons who are excluded from permit requirements by 9VAC25-610-50.

"Agricultural use" means utilizing groundwater for the purpose of agricultural, silvicultural, horticultural, or aquacultural operations. Agricultural use includes withdrawals for turf farm operations, but does not include withdrawals for landscaping activities or turf installment and maintenance associated with landscaping activities.

"Applicant" means a person filing an application to initiate or enlarge a groundwater withdrawal in a groundwater management area.

"Area of impact" means the areal extent of each aquifer where more than one foot of drawdown is predicted to occur due to a proposed withdrawal.

"Beneficial use" includes domestic (including public water supply), agricultural, commercial, and industrial uses.

"Board" means the State Water Control Board. When used outside the context of the promulgation of regulations, including regulations to establish general permits, "board" means the Department of Environmental Quality.

"Consumptive use" means the withdrawal of groundwater, without recycle of said waters to their source of origin.

"Controversial permit" means a water permitting action for which a public hearing has been granted pursuant to 9VAC25-610-270 and 9VAC25-610-275.

"Department" means the Department of Environmental Quality.

"Director" means the Director of the Department of Environmental Quality.

"Draft permit" means a prepared document indicating the department's tentative decision relative to a permit action.

"General permit" means a groundwater withdrawal permit authorizing the withdrawal of groundwater in a groundwater management area under specified conditions, including the size of the withdrawal or the aquifer or confining unit from which the withdrawal is to be made.

"Geophysical investigation" means any hydrogeologic evaluation to define the hydrogeologic framework of an area or determine the hydrogeologic properties of any aquifer or confining unit to the extent that withdrawals associated with such investigations do not result in unmitigated adverse impacts to existing groundwater users. Geophysical investigations include pump tests and aquifer tests.

"Groundwater" means any water, except capillary moisture, beneath the land surface in the zone of saturation or beneath the bed of any stream, lake, reservoir, or other body of surface water wholly or partially within the boundaries of this Commonwealth, whatever the subsurface geologic structure in which such water stands, flows, percolates, or otherwise occurs.

"Human consumption" means the use of water to support human survival and health, including drinking, bathing, showering, cooking, dishwashing, and maintaining hygiene.

"Instream beneficial uses" means uses including the protection of fish and wildlife resources and habitat, maintenance of waste assimilation, recreation, navigation, and cultural and aesthetic values. The preservation of instream flows for purposes of the protection of navigation, maintenance of waste assimilation capacity, the protection of fish and wildlife resources and habitat, recreation, and cultural and aesthetic values is an instream beneficial use of Virginia's waters.

"Mitigate" means to take actions necessary to assure ensure that all existing groundwater users at the time of issuance of a permit or special exception who experience adverse impacts continue to have access to the amount and quality of groundwater needed for existing uses.

"Permit" means a groundwater withdrawal permit issued under the Ground Water Management Act of 1992 permitting the withdrawal of a specified quantity of groundwater under specified conditions in a groundwater management area.

"Permittee" means a person that currently has an effective groundwater withdrawal permit issued under the Ground Water Act of 1992.

"Person" means any and all persons, including individuals, firms, partnerships, associations, public or private institutions, municipalities or political subdivisions, governmental agencies, or private or public corporations organized under the laws of this Commonwealth or any other state or country.

"Practicable" means available and capable of being done after taking into consideration cost, existing technology, and logistics in light of overall project purposes.

"Private well" means, as defined in § 32.1-176.3 of the Code of Virginia, any water well constructed for a person on land that is owned or leased by that person and is usually intended for household, groundwater source heat pump, agricultural use, industrial use, or other nonpublic water well.

"Public hearing" means a fact finding fact-finding proceeding held to afford interested persons an opportunity to submit factual data, views, and comments to the department.

"Public water supply" means a system that provides water for human consumption through pipes or other constructed conveyances to at least 15 service connections or serves an average of at least 25 people for at least 60 days a year. A public water supply may be publicly or privately owned.

"Salt water intrusion" means the encroachment of saline waters in any aquifer that creates adverse impacts to existing groundwater users or is counter to the public interest.

"Special exception" means a document issued by the department for withdrawal of groundwater in unusual situations where requiring the user to obtain a groundwater withdrawal permit would be contrary to the purpose of the Ground Water Management Act of 1992. Special exceptions allow the withdrawal of a specified quantity of groundwater under specified conditions in a groundwater management area.

"Supplemental drought relief well" means a well permitted to withdraw a specified amount of groundwater to meet human consumption needs during declared drought conditions after mandatory water use restrictions have been implemented.

"Surface water" means all state waters that are not groundwater as groundwater is defined in § 62.1-255 of the Code of Virginia.

"Surface water and groundwater conjunctive use system" means an integrated water supply system wherein surface water is the primary source and groundwater is a supplemental source that is used to augment the surface water source when the surface water source is not able to produce the amount of water necessary to support the annual water demands of the system.

"Surficial aquifer" means the upper surface of a zone of saturation, where the body of groundwater is not confined by an overlying impermeable zone.

"Water loss" means the difference between the estimated or measured volume of water withdrawn and the estimated or measured volume applied to the beneficial use.

"Water loss audit" means the review of records and data that traces the flow of water from its withdrawal through distribution and application to the beneficial use.

"Water well systems provider" means any individual who is certified by the Board for Contractors in accordance with § 54.1-1128 et seq. of the Code of Virginia and who is engaged in drilling, installation, maintenance, or repair of water wells, water well pumps, ground source heat exchangers, and other equipment associated with the construction, removal, or repair of water wells, water well systems, and ground source heat pump exchangers to the point of connection to the ground source heat pump.

"Well" means any artificial opening or artificially altered natural opening, however made, by which groundwater is sought or through which groundwater flows under natural pressure or is intended to be withdrawn.

"Withdrawal system" means (i) one or more wells or withdrawal points located on the same or contiguous properties under common ownership for which the withdrawal is applied to the same beneficial use or (ii) two or more connected wells or withdrawal points that are under common ownership but are not necessarily located on contiguous properties.

9VAC25-610-100. Water conservation and management plans.

A. Any application to initiate a new withdrawal or expand an existing withdrawal in any groundwater management area or the reapplication at the end of a permit cycle for all permits shall require a water conservation and management plan before the application or reapplication is considered complete. The department shall review all water conservation and management plans and assure ensure that such plans contain all elements required in subsection B of this section. The approved plan shall become an enforceable part of the approved permit.

B. A water conservation and management plan is an operational plan to be referenced and implemented by the permittee. Water conservation and management plans shall be consistent with local and regional water supply plans in the applicant's geographic area developed as required by 9VAC25-780. The water conservation and management plan shall be specific to the type of water use and include the following:

1. For municipal and nonmunicipal public water supplies a public water supply, the required water conservation and management plan shall include:

a. Where practicable, the plan should require use of water-saving equipment and processes for all water users including technological, procedural, or programmatic improvements to the facilities and processes to decrease the amount of water withdrawn or to decrease water demand. The goal of these requirements is to assure the most efficient use of groundwater. Information on the water-saving alternatives examined and the water savings associated with the alternatives shall be provided. Water conservation and management plans shall discuss high volume water consumption by users on the system and where conservation measures have previously been implemented and shall be applied. Also, where appropriate, the use of water-saving fixtures in new and renovated plumbing as provided in the Uniform Statewide Building Code (13VAC5-63) shall be identified in the plan; A water auditing plan for an annual water loss audit in accordance with the American Water Works Association (AWWA) methodology for water loss auditing, using the most recent version of the AWWA Water Audit Software or another methodology approved by the department that estimates water loss.

(1) A water loss audit using an approved methodology shall be conducted annually. The requirement to conduct an annual water loss audit shall begin upon permit issuance. By the end of the first year of the permit term, the permittee shall submit documentation to the department that the water loss audit has been initiated. This documentation shall include activities completed during the first year of the permit term.

(2) The applicant shall report the results of the annual water loss audits in a report submitted at a minimum every three years. The report shall also include any revisions to the water auditing plan over the short [ term ] and long term.

b. A water loss reduction program, which defines the applicant's leak detection and repair program. The water loss reduction program plan shall include requirements for an audit of the total amount of groundwater used in the distribution system and operational processes during the first two years of the permit cycle. Implementation of a be submitted as a component of the water conservation and management plan. The leak detection and repair program plan shall be required within one year of the date the permit is issued. The program shall include a schedule for inspection of equipment and piping for leaks; indicate how its implementation will be informed by the results of the annual water loss audit process and shall be updated during each new permit term. The plan shall include:

(1) A description of how the water loss audit results are expected to inform prioritization of actions to address water loss;

(2) Where practicable, a process for the identification of equipment needs to quantify and reduce water loss;

(3) Where practicable, a schedule for inspection of equipment and distribution systems for actual water losses; and

(4) In the report required by subdivision 1 a (2) of this subsection, a description of the leak detection and repair plan's effectiveness in addressing water loss, including revisions to those elements of the leak detection and repair plan that can be improved over the short [ term ] and long term.

c. Other components of a water conservation and management plan include:

(1) A water use education program that contains requirements for the education of water users and training of employees controlling water consuming processes to assure ensure that water conservation principles are well known by the users of the resource. The program shall include a schedule for information distribution and the type of materials used;

d. (2) An evaluation of water reuse options and assurances that water shall be reused in all instances where reuse is practicable. Potential for expansion of the existing reuse practices or adoption of additional reuse practices shall also be included; and

e. (3) Where practicable, a requirement for the use of water-saving equipment and processes for all water users, including technological, procedural, or programmatic improvements to the facilities and processes to decrease the amount of water withdrawn or to decrease water demand. Information on the water-saving alternatives examined and the water savings associated with the alternatives shall be provided. Water conservation and management plans shall discuss high volume water consumption by users on the system and where conservation measures have previously been implemented and shall be applied. Where appropriate, the use of water-saving fixtures in new and renovated plumbing, as provided in the Virginia Uniform Statewide Building Code (13VAC5-63), shall also be identified in the plan; and

(4) Requirements for mandatory water use reductions during water shortage emergencies declared by the local governing body or water authority consistent with §§ 15.2-923 and 15.2-924 of the Code of Virginia. This shall include, where appropriate, ordinances in municipal systems prohibiting the waste of water generally and requirements providing for mandatory water use restrictions in accordance with drought response and contingency ordinances implemented to comply with 9VAC25-780-120 during water shortage emergencies. The water conservation and management plan shall also contain requirements for mandatory water use restrictions during water shortage emergencies that restricts or prohibits all nonessential uses such as lawn watering, car washing, and similar nonessential residential, industrial, and commercial uses for the duration of the water shortage emergency. Penalties for failure to comply with mandatory water use restrictions shall be included in municipal system plans.

2. For nonpublic water supply applicants - a commercial and industrial users user, the required water conservation and management plan shall include:

a. Where applicable, the plan should require use of water-saving equipment and processes for all water users including technological, procedural, or programmatic improvements to the facilities and processes to decrease the amount of water withdrawn or to decrease water demand. The goal of these requirements is to assure the most efficient use of groundwater. Information on the water-saving alternatives examined and the water savings associated with the alternatives shall be provided. Also, where appropriate, the use of water-saving fixtures in new and renovated plumbing as provided in the Uniform Statewide Building Code (13VAC5-63) shall be identified in the plan; A water auditing plan for a water loss audit to be conducted beginning in the first three years of the permit term. The plan shall include a description of the methodology used to estimate the water loss for the operation and the quantity of water used throughout the facility.

(1) A water loss audit using this methodology shall be conducted once every three years. The requirement to conduct a water loss audit shall begin upon permit issuance. Documentation shall include activities completed during the first three years of the permit term.

(2) The applicant shall conduct a water loss audit and report the results of the water loss audit in a report submitted every three years.

b. A water loss reduction program, which defines the applicant's leak detection and repair program. The water loss reduction program plan shall include requirements for an audit of the total amount of groundwater used in the distribution system and operational processes during the first two years of the permit cycle. Implementation of a be submitted as a component of the water conservation and management plan. The leak detection and repair program shall be required within one year of the date the permit is issued plan shall indicate how its implementation will be informed by the results of the water loss audit process and shall be updated during each new permit term. The program plan shall include a schedule for inspection of equipment and piping for leaks;:

(1) A description of how the water loss audit results are expected to inform prioritization of actions to address water loss;

(2) Where practicable, a process for the identification of equipment needs to quantify and reduce water loss;

(3) Where practicable, a schedule for inspection of equipment and piping systems for actual water losses;

(4) Where practicable, a requirement for use of water-saving equipment and processes, including technological, procedural, or programmatic improvements to the facilities and processes to decrease the amount of water withdrawn or to decrease water demand. The goal of these requirements is to ensure the most efficient use of groundwater. Information on the water-saving alternatives examined and the water savings associated with the alternatives shall be provided. Water conservation and management plans shall discuss high volume water processes in the facility and where conservation measures have previously been implemented and shall be applied. Where appropriate, the use of water-saving fixtures in new and renovated plumbing, as provided in the Virginia Uniform Statewide Building Code, shall also be identified in the plan; and

(5) In the report required by subdivision 2 a (2) of this subsection, a description of the plan's effectiveness in addressing water loss, including revisions to those elements of the water conservation and management plan that can be improved over the short [ term ] and long term.

c. Other components of a water conservation and management plan include:

(1) A water use education program that contains requirements for the education of water users and training of employees controlling water consuming processes to assure ensure that water conservation principles are well known by the users of the resource. The program shall include a schedule for information distribution and the type of materials used;

d. (2) An evaluation of water reuse options and assurances that water shall be reused in all instances where reuse is practicable. Potential for expansion of the existing reuse practices or adoption of additional reuse practices shall also be included; and

e. (3) Where practicable, actions to encourage or provide incentives for the use of water-saving fixtures in new and renovated plumbing, as provided under the Virginia Uniform Statewide Building Code, shall be identified in the plan; and

(4) Requirements for complying with mandatory water use reductions during water shortage emergencies declared by the local governing body or water authority in accordance with §§ 15.2-923 and 15.2-924 of the Code of Virginia. This shall include, where appropriate, ordinances prohibiting the waste of water generally and requirements providing for mandatory water use restrictions in accordance with drought response and contingency ordinances implemented to comply with 9VAC25-780-120 during water shortage emergencies. The water conservation and management plan shall also contain requirements for mandatory water use restrictions during water shortage emergencies that restricts or prohibits all nonessential uses such as lawn watering, car washing, and similar nonessential industrial and commercial uses for the duration of the water shortage emergency.

3. For nonpublic water supply applicants - an agricultural users user, the required water conservation and management plan shall include:

a. Requirements for the use of water-saving plumbing and processes to decrease the amount of water withdrawn or to decrease water demand. Plans submitted for the use of groundwater for irrigation shall identify the specific type of irrigation system that will be utilized, the efficiency rating of the irrigation system in comparison to less efficient systems, the irrigation schedule used to minimize water demand, and the crop watering requirements. Multiple types of irrigation methods may be addressed in the plan. For livestock watering operations, plans shall include livestock watering requirements (per head) and processes to minimize waste of water. These requirements shall assure that the most practicable use is made of groundwater. If these options are not implemented in the plan, information on the water-saving alternatives examined and the water savings associated with the alternatives shall be provided; A water auditing plan for an annual water loss audit that shall be conducted annually or periodically based on agricultural management plans or irrigation management plans, including the anticipated crop rotation schedule or livestock growth stages. The water auditing plan shall include an estimate of water loss for the agricultural operation and a description of the methodology used to determine the quantity of water used throughout the agricultural operation.

(1) A water loss audit using this methodology shall be conducted. The requirement to conduct a water loss audit shall begin upon permit issuance. By the end of the first year of the permit term, the permittee shall submit documentation to the department that the water loss audit has been initiated. This documentation shall include activities completed during the first year of the permit term.

(2) The applicant shall report the results of the water loss audit in a report submitted at a minimum every three years.

b. A water loss reduction program, which defines the applicant's leak detection and repair program. The water loss reduction program plan shall include requirements for an audit of the total amount of groundwater used in the distribution system and operational processes during the first two years of the permit cycle. Implementation of a be submitted as a component of the water conservation and management plan. The leak detection and repair program plan shall be required within one year of the date the permit is issued. The program shall include a schedule for inspection of equipment and piping for leaks;:

(1) A description of how the water loss audit results are expected to inform prioritization of actions to address water loss;

(2) For plans submitted for the use of groundwater for irrigation, identification of the specific type of irrigation system that will be utilized, the efficiency rating of the irrigation system in comparison to less efficient systems, the irrigation management methods used to minimize water demand, and the anticipated crop watering requirements. Multiple types of irrigation methods may be addressed in the plan. For livestock watering operations, plans shall include livestock watering requirements (per head) and processes to minimize waste of water. If these options are not implemented in the plan, information on the water-saving alternatives examined and the water savings associated with the alternatives shall be provided;

(3) Where practicable, a schedule for inspection of equipment and distribution systems for water loss;

(4) Where practicable, the use of water-saving equipment and processes, including technological, procedural, or programmatic improvements to the facilities and processes to decrease the amount of water withdrawn or to decrease water loss. The goal of these requirements is to ensure the most efficient use of groundwater. Information on the water-saving alternatives examined and the water savings associated with the alternatives should be provided. Water conservation and management plans shall discuss high volume water consumption by processes in the agricultural operation and where conservation measures have previously been implemented and shall be applied. Where practicable, the use of water-saving fixtures in new and renovated plumbing, as provided in the Virginia Uniform Statewide Building Code, shall also be identified in the plan; and

(5) In the report required by subdivision 3 a (2) of this subsection, a description of the leak detection and repair plan's effectiveness in addressing water loss, including revisions to those elements of the leak detection and repair plan that can be improved over the short [ term ] and long term.

c. Other components of a water conservation and management plan include:

(1) A water use education program that contains requirements for the training of employees controlling water consuming processes to assure ensure that water conservation principles are well known by the users of the resource. The program shall include a schedule for training employees. This requirement may be met through training employees on water use requirements contained in irrigation management plans or livestock management plans;

d. (2) An evaluation of potential water reuse options and assurances that water shall be reused in all instances where reuse is practicable and not prohibited by other regulatory programs;. Potential for expansion of the existing reuse practices or adoption of additional reuse practices shall also be included; and

e. (3) Requirements for mandatory water use reductions during water shortage emergencies and compliance with ordinances prohibiting the waste of water generally. This shall include requirements providing for mandatory water use restrictions in accordance with drought response and contingency ordinances implemented to comply with 9VAC25-780-120 during water shortage emergencies. f.; and

(4) The permittee may submit portions of Agricultural Management Plans or Irrigation Management Plans developed to comply with requirements of federal or state laws, regulations, or guidelines to demonstrate the requirements of subdivisions B 3 a through d B 3 c (3) of this section are being achieved.

TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING

BOARD OF PHARMACY

Proposed Regulation

Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-10, 18VAC110-20-505, 18VAC110-20-690, 18VAC110-20-710, 18VAC110-20-720; adding 18VAC110-20-591, 18VAC110-20-721; repealing 18VAC110-20-500).

Statutory Authority: §§ 54.1-2400 and 54.1-3307 of the Code of Virginia.

Public Hearing Information:

August 11, 2025 - 9:30 a.m. - Department of Health Professions, Commonwealth Conference Center, Board Room Three, 9960 Mayland Drive, Henrico, VA 23223-1463.

Public Comment Deadline: September 12, 2025.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4456, fax (804) 527-4472, or email caroline.juran@dhp.virginia.gov.

Basis: Regulations of the Board of Pharmacy are promulgated under the general authority of § 54.1-2400 of the Code of Virginia, which authorizes health regulatory boards to promulgate regulations that are reasonable and necessary to effectively administer the regulatory system.

Purpose: Emergency medical services (EMS) agencies predominantly rely on hospital drug kit exchanges to ensure EMS vehicles have adequate drug stock for emergency needs. Changes to federal regulations, however, will make hospital drug kit exchanges nonexistent, potentially leaving EMS vehicles without reliable sources of drugs to use when transporting patients or responding to emergencies. In consultation with the Virginia Department of Health and stakeholders, the board has determined that the proposed amendments are necessary and imperative to ensure continued provision of drugs for members of the public receiving emergency care, which will protect public health, safety, and welfare.

Substance: The proposed amendments (i) allow EMS agencies and regional EMS councils to apply for a controlled substance registration (CSR) and use a hub-and-spoke model to service-designated locations of the entity holding the CSR and U.S. Drug Enforcement Administration registration; (ii) set requirements for health care practitioners who are necessary to maintain, audit, and dispense drug stock and requirements for prescribers connected to the CSR holder; (iii) provide certain allowances for EMS agencies and regional EMS councils regarding drug storage, alarm systems, and audits of drugs; and (iv) permit transfer of drugs between locations controlled by a hub CSR and between CSR holders.

Issues: The primary advantage to the public is a reliable drug stock on EMS vehicles serving the Commonwealth. There are no disadvantages to the public. There are no primary advantages or disadvantages to the agency or the Commonwealth.

Department of Planning and Budget Economic Impact Analysis:

The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Code of Virginia and Executive Order 19. The analysis presented represents DPB's best estimate of the potential economic impacts as of the date of this analysis.¹

Summary of the Proposed Amendments to Regulation. In response to a 2024 change in federal requirements, the Board of Pharmacy (board) is proposing to make permanent an emergency regulation that updates the procedures for emergency drug kits used by emergency medical services (EMS) agencies.

Background. Prior to 2024, EMS providers in Virginia were able to return partially used drug boxes or kits to hospital pharmacies, which then supplied the providers with new kits to use in EMS vehicles for free. However, due to federal regulatory changes, the board became aware that hospitals would no longer engage in this practice beyond November 27, 2024, which was the day that the U.S. Food and Drug Administration was scheduled to begin enforcing additional Drug Supply Chain Security Act requirements. Consequently, the board needed to develop a new system for EMS providers to obtain, store, and replace these drug kits. The board worked together with EMS stakeholders to develop a new hub-and-spoke system to resolve these issues, which included a requirement that the EMS agencies obtain a controlled substance registration (CSR) from the board. Subsequent to obtaining the CSR, EMS agencies need to obtain registration from the U.S. Drug Enforcement Administration (DEA) to purchase their own drug stock and transfer it to associated EMS stations. The emergency regulation implementing the distribution system change became effective on August 20, 2024. Generally, the emergency regulation and the proposed permanent regulation establish the requirements for health care practitioners to maintain, audit, and dispense drug stock; list the requirements for prescribers connected to the CSR holders; create allowances for EMS agencies and regional EMS councils pertaining to drug storage, alarm systems, and drug audits; and permit the transfer of drugs between locations controlled by a hub and between CSR holders. In response to public comments received following publication of the emergency stage, the board is proposing one change. This change, which would allow for the storage of controlled substances at a location where an EMS agency approves an EMS vehicle to be stored, was made at the request of first responders in more rural parts of the state, who often take their vehicles home at night. They noted that due to the geography and the extensive distances involved, being required to return to a central location each day and then go back to retrieve the drugs may result in delays in being able to reach and treat emergency patients in a timely fashion.

Estimated Benefits and Costs. Since the emergency regulation has been in effect, the board has issued 293 CSRs to EMS agencies or regional EMS councils.² The initial registration and annual renewal fees for a CSR are $120. According to DEA, EMS agencies are exempt from federal registration fees if they are associated with county, state or local government. For nonexempt applicants, the fee is $888 for a period of three years. The increased cost for EMS agencies from paying for and handling the medications likely substantially exceed the registration fees. Under the prior system where hospitals provided EMS agencies drug kits for free, the agencies did not have the pre-existing pharmacy infrastructure, staff, purchasing power, and supply chains that exist for hospitals. The EMS agencies now need to pay for that, as well as the medications themselves. A news source reported that New Kent County anticipates a cost of $24,000 annually to provide its own drugs to emergency personnel.³ No data is yet available for the actual costs incurred by the EMS agencies since hospitals have stopped providing the kits for free and the emergency regulation has been in effect.⁴ The change in system and associated costs are due to the changes in federal regulation. In contrast, the proposed state regulatory changes have been made to allow patients to benefit from continuing to receive drugs in emergency situations. Thus, the benefits are attributable to the proposed regulation, and the costs are attributable to the federal regulation is net beneficial.

Businesses and Other Entities Affected. The Virginia Office of Emergency Medical Services estimated that between 500 and 1,000 EMS agencies may need to obtain a CSR, and 293 have thus far. The Code of Virginia requires DPB to assess whether an adverse impact may result from the proposed regulation.⁵ An adverse impact is indicated if there is any increase in net cost or reduction in net revenue for any entity, even if the benefits exceed the costs for all entities combined. Because the increase in costs for EMS agencies is due to the federal regulatory change, and not the proposed amendments to this regulation, no adverse impact is indicated.

Small Businesses⁶ Affected.⁷ The proposed amendments do not adversely affect small businesses.

Localities⁸ Affected.⁹ The change in system particularly affects local governments that provide funding to EMS agencies, but that is due to the change in federal regulation.

Projected Impact on Employment. There may be a small increase in employment at EMS agencies in order to provide the newly needed services. Again, this is due to the change in federal regulation.

Effects on the Use and Value of Private Property. The proposed amendments affect neither the use and value of private property nor real estate development costs.

_____________________________

¹ Section 2.2-4007.04 of the Code of Virginia requires that such economic impact analyses determine the public benefits and costs of the proposed amendments. Further the analysis should include but not be limited to: (1) the projected number of businesses or other entities to whom the proposed regulatory action would apply, (2) the identity of any localities and types of businesses or other entities particularly affected, (3) the projected number of persons and employment positions to be affected, (4) the projected costs to affected businesses or entities to implement or comply with the regulation, and (5) the impact on the use and value of private property.

² Source: Department of Health Professions..

³ See page six of the Agency Background Document: https://townhall.virginia.gov/L/GetFile.cfm?File=30\6452\10559\AgencyStatement_DHP_10559_v1.pdf.

⁴ Source: Department of Health Professions and EMS stakeholders who worked with the board.

⁵ Pursuant to § 2.2-4007.04 D: In the event this economic impact analysis reveals that the proposed regulation would have an adverse economic impact on businesses or would impose a significant adverse economic impact on a locality, business, or entity particularly affected, the Department of Planning and Budget shall advise the Joint Commission on Administrative Rules, the House Committee on Appropriations, and the Senate Committee on Finance. Statute does not define "adverse impact," state whether only Virginia entities should be considered, nor indicate whether an adverse impact results from regulatory requirements mandated by legislation.

⁶ Pursuant to § 2.2-4007.04, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

⁷ If the proposed regulatory action may have an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include: (1) an identification and estimate of the number of small businesses subject to the proposed regulation, (2) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the proposed regulation, including the type of professional skills necessary for preparing required reports and other documents, (3) a statement of the probable effect of the proposed regulation on affected small businesses, and (4) a description of any less intrusive or less costly alternative methods of achieving the purpose of the proposed regulation. Additionally, pursuant to § 2.2-4007.1 of the Code of Virginia, if there is a finding that a proposed regulation may have an adverse impact on small business, the Joint Commission on Administrative Rules shall be notified.

⁸ "Locality" can refer to either local governments or the locations in the Commonwealth where the activities relevant to the regulatory change are most likely to occur.

⁹ Section 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

Agency Response to Economic Impact Analysis: The Board of Pharmacy concurs with the economic impact analysis prepared by the Department of Planning and Budget.

Summary:

The proposed amendments align the regulation with new federal requirements of the Drug Supply Chain Security Act (21 USC § 351 et seq.) and the Protecting Patient Access to Emergency Medications Act (21 USC § 823) that ensure emergency medical services (EMS) providers can provide drugs to patients as needed. The proposed amendments (i) allow EMS agencies and regional EMS councils to apply for a controlled substance registration (CSR) and use a hub-and-spoke model to service designated locations of the entity holding the CSR and U.S. Drug Enforcement Administration registration; (ii) establish requirements for health care practitioners who are needed to maintain, audit, and dispense drug stock and requirements for prescribers connected to the CSR holder; (iii) provide certain allowances for EMS agencies and regional EMS councils regarding drug storage, alarm systems, and audits of drugs; and (iv) permit transfer of drugs between locations controlled by a hub CSR and between CSR holders.

18VAC110-20-10. Definitions.

In addition to words and terms defined in §§ 54.1-3300 and 54.1-3401 of the Code of Virginia, the following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise:

"Acquisition" of an existing entity permitted, registered, or licensed by the board means (i) the purchase or transfer of all or substantially all of the assets of the entity or of any corporation that owns or controls the entity; (ii) the creation of a partnership by a sole proprietor or change in partnership composition; (iii) the acquiring of 50% or more of the outstanding shares of voting stock of a corporation owning the entity or of the parent corporation of a wholly owned subsidiary owning the entity, except that this shall not apply to any corporation the voting stock of which is actively traded on any securities exchange or in any over-the-counter market; or (iv) the merger of a corporation owning the entity or of the parent corporation of a wholly owned subsidiary owning the entity with another business or corporation.

"Actively reports" means reporting all dispensing errors and analyses of such errors to a patient safety organization as soon as practical or at least within 30 days of identifying the error.

"Alternate delivery site" means a location authorized in 18VAC110-20-275 to receive dispensed prescriptions on behalf of and for further delivery or administration to a patient.

"Analysis" means a review of the findings collected and documented on each dispensing error, assessment of the cause, and any factors contributing to the dispensing error, and any recommendation for remedial action to improve pharmacy systems and workflow processes to prevent or reduce future errors.

"Authorized collector" means a narcotic treatment program, hospital or clinic with an on-site pharmacy, or pharmacy that is authorized by the U.S. Drug Enforcement Administration to receive drugs for the purpose of destruction.

"Beyond-use date" means the date beyond which the integrity of a compounded, repackaged, or dispensed drug can no longer be assured ensured and as such is deemed to be adulterated or misbranded as defined in §§ 54.1-3461 and 54.1-3462 of the Code of Virginia.

"Board" means the Virginia Board of Pharmacy.

"Chart order" means a lawful order for a drug or device entered on the chart or in a medical record of a patient by a prescriber or the prescriber's designated agent.

"Compliance packaging" means packaging for dispensed drugs that is comprised of a series of containers for solid oral dosage forms and designed to assist the user in administering or self-administering the drugs in accordance with directions for use.

"Correctional facility" means any prison, penitentiary, penal facility, jail, detention unit, or other facility in which persons are incarcerated by government officials.

"DEA" means the U.S. Drug Enforcement Administration.

"Designated location" means a station, EMS agency substation or satellite location, or other location approved by the DEA, if applicable, and designated by an EMS agency or regional EMS council.

"Dispensing error" means one or more of the following discovered after the final verification by the pharmacist, regardless of whether the patient received the drug:

1. Variation from the prescriber's prescription drug order, including:

a. Incorrect drug;

b. Incorrect drug strength;

c. Incorrect dosage form;

d. Incorrect patient; or

e. Inadequate or incorrect packaging, labeling, or directions.

2. Failure to exercise professional judgment in identifying and managing:

a. Known therapeutic duplication;

b. Known drug-disease contraindications;

c. Known drug-drug interactions;

d. Incorrect drug dosage or duration of drug treatment;

e. Known drug-allergy interactions;

f. A clinically significant, avoidable delay in therapy; or

g. Any other significant, actual, or potential problem with a patient's drug therapy.

3. Delivery of a drug to the incorrect patient.

4. Variation in bulk repackaging or filling of automated devices, including:

a. Incorrect drug;

b. Incorrect drug strength;

c. Incorrect dosage form; or

d. Inadequate or incorrect packaging or labeling.

"Drug donation site" means a permitted pharmacy that specifically registers with the board for the purpose of receiving or redispensing eligible donated prescription drugs pursuant to § 54.1-3411.1 of the Code of Virginia.

"Electronic prescription" means a written prescription that is generated on an electronic application and is transmitted to a pharmacy as an electronic data file; Schedules II through V prescriptions shall be transmitted in accordance with 21 CFR Part 1300.

"Emergency medical services provider" or "EMS provider" means the same as defined in 12VAC5-31-10.

"Emergency medical services vehicle" or "EMS vehicle" has the same meaning prescribed in § 32.1-111.1 of the Code of Virginia.

"EMS agency" means emergency medical services has the same meaning as prescribed in § 32.1-111.1 of the Code of Virginia.

"Expiration date" means that date placed on a drug package by the manufacturer or repacker beyond which the product may not be dispensed or used.

"Faxed prescription" means a written prescription or order that is transmitted by an electronic device that sends over telephone lines the exact image to the receiver (pharmacy) in a hard copy form.

"FDA" means the U.S. Food and Drug Administration.

"Floor stock" means a supply of drugs that have been distributed for the purpose of general administration by a prescriber or other authorized person pursuant to a valid order of a prescriber.

"Forgery" means a prescription that was falsely created, falsely signed, or altered.

"Generic drug name" means the nonproprietary name listed in the United States Pharmacopeia-National Formulary (USP-NF) or in the United States Adopted Names (USAN) and the USP Dictionary of Drug Names.

"Hospital" or "nursing home" means those facilities as defined in Title 32.1 of the Code of Virginia or as defined in regulations by the Virginia Department of Health.

"Hospital-owned" means, with respect to an EMS agency, owned by a hospital.

"Initials" means the first letters of a person's name or other unique personal identifier.

"Long-term care facility" means a nursing home, retirement care, mental care, or other facility or institution that provides extended health care to resident patients.

"NABP" means the National Association of Boards of Pharmacy.

"Nuclear pharmacy" means a pharmacy providing radiopharmaceutical services.

"On duty" means that a pharmacist is on the premises at the address of the permitted pharmacy and is available as needed.

"On-hold prescription" means a valid prescription that is received and maintained at the pharmacy for initial dispensing on a future date.

"Other EMS vehicle" means a vehicle used by the EMS agency or regional EMS council for the purpose of providing or facilitating emergency medical care or transporting controlled substances to and from the registered and designated locations. Such vehicles must be either owned by or registered to an EMS agency, regional EMS council, or jurisdiction and operated by an EMS agency or regional EMS council.

"Patient safety organization" means an organization that has as its primary mission continuous quality improvement under the Patient Safety and Quality Improvement Act of 2005 (P.L. 109-41) and is credentialed by the Agency for Healthcare Research and Quality.

"Permitted physician" means a physician who is licensed pursuant to § 54.1-3304 of the Code of Virginia to dispense drugs to persons to whom or for whom pharmacy services are not reasonably available.

"Perpetual inventory" means an ongoing system for recording quantities of drugs received, dispensed, or otherwise distributed by a pharmacy.

"Personal supervision" means the pharmacist must be physically present and render direct, personal control over the entire service being rendered or act being performed. Neither prior nor future instructions shall be sufficient nor shall supervision rendered by telephone, written instructions, or by any mechanical or electronic methods be sufficient.

"Pharmacy closing" means that the permitted pharmacy ceases pharmacy services or fails to provide for continuity of pharmacy services or lawful access to patient prescription records or other required patient records for the purpose of continued pharmacy services to patients.

"PIC" means the pharmacist-in-charge of a permitted pharmacy.

"Practice location" means any location in which a prescriber evaluates or treats a patient.

"Prescription department" means any contiguous or noncontiguous areas used for the compounding, dispensing, and storage of all Schedules II through VI drugs and devices and any Schedule I investigational drug.

"Quality assurance plan" means a plan approved by the board for ongoing monitoring, measuring, evaluating, and, if necessary, improving the performance of a pharmacy function or system.

"Radiopharmaceutical" means any drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any nonradioactive reagent kit or radionuclide generator that is intended to be used in the preparation of any such substance but does not include drugs such as carbon-containing compounds or potassium-containing salts that include trace quantities of naturally occurring radionuclides. The term also includes any biological product that is labeled with a radionuclide or intended solely to be labeled with a radionuclide.

"Regional EMS council" means an organization designated by the State Board of Health pursuant to § 32.1-111.4:2 of the Code of Virginia.

"Registered EMS agency headquarters" means the principal office and primary business location of an EMS agency that maintains a controlled substances registration issued by the board or a hospital-owned EMS agency that is covered by the registration of a hospital.

"Registered location" means, for the purposes of emergency medical services, a location that appears on a DEA certificate of registration or controlled substances registration issued to an EMS agency or regional EMS council, which shall be the location at which the agency or council receives Schedules II through VI controlled substances from those entities authorized to distribute controlled substances.

"Repackaged drug" means any drug removed from the manufacturer's original package and placed in different packaging.

"Robotic pharmacy system" means a mechanical system controlled by a computer that performs operations or activities relative to the storage, packaging, compounding, labeling, dispensing, or distribution of medications and collects, controls, and maintains all transaction information.

"Safety closure container" means a container that meets the requirements of the federal Poison Prevention Packaging Act of 1970 (15 USC §§ 1471-1476), that is, in testing such containers, that 85% of a test group of 200 children of ages 41-52 months are unable to open the container in a five-minute period and that 80% fail in another five minutes after a demonstration of how to open it and that 90% of a test group of 100 adults must be able to open and close the container.

"Satellite pharmacy" means a pharmacy that is noncontiguous to the centrally permitted pharmacy of a hospital but at the location designated on the pharmacy permit.

"Special packaging" means packaging that is designed or constructed to be significantly difficult for children younger than five years of age to open to obtain a toxic or harmful amount of the drug contained therein within a reasonable time and not difficult for normal adults to use properly but does not mean packaging that all such children cannot open or obtain a toxic or harmful amount within a reasonable time.

"Special use permit" means a permit issued to conduct a pharmacy of a special scope of service that varies in any way from the provisions of any board regulation.

"Station" means an enclosed structure that houses one or more EMS vehicles or other EMS vehicles in the state in which the EMS agency is registered that is actively and primarily being used for emergency response by the EMS agency.

"Storage temperature" means those specific directions stated in some monographs with respect to the temperatures at which pharmaceutical articles shall be stored, where it is considered that storage at a lower or higher temperature may produce undesirable results. The conditions are defined by the following terms:

1. "Cold" means any temperature not exceeding 8°C (46°F). A refrigerator is a cold place in which temperature is maintained thermostatically between 2° and 8°C (36° and 46°F). A freezer is a cold place in which the temperature is controlled between -25° and -10°C (-13° and 14°F). In those instances in which articles may have a recommended storage condition below -20°C (-4°F), the temperature of the storage location should be controlled to plus or minus 10 degrees.

2. "Room temperature" means the temperature prevailing in a working area.

3. "Controlled room temperature" means a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C (77°F); and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses.

4. "Warm" means any temperature between 30° and 40°C (86° and 104°F).

5. "Excessive heat" means any temperature above 40°C (104°F).

6. "Protection from freezing" means where, in addition to the risk of breakage of the container, freezing subjects a product to loss of strength or potency or to the destructive alteration of its characteristics, the container label bears an appropriate instruction to protect the product from freezing.

7. "Cool" means any temperature between 8° and 15°C (46° and 59°F).

"Terminally ill" means a patient with a terminal condition as defined in § 54.1-2982 of the Code of Virginia.

"Ultimate user" means a person who has lawfully obtained, and who possesses, a controlled substance for his that person's own use or for the use of a member of his that person's household or for an animal owned by him that person or a member of his that person's household.

"Unit dose container" means a container that is a single-unit container, as defined in United States Pharmacopeia-National Formulary, for articles intended for administration by other than the parenteral route as a single dose, direct from the container.

"Unit dose package" means a container that contains a particular dose ordered for a patient.

"Unit dose system" means a system in which multiple drugs in unit dose packaging are dispensed in a single container, such as a medication drawer or bin, labeled only with patient name and location. Directions for administration are not provided by the pharmacy on the drug packaging or container but are obtained by the person administering directly from a prescriber's order or medication administration record.

"USP-NF" means the United States Pharmacopeia-National Formulary.

"Well-closed container" means a container that protects the contents from extraneous solids and from loss of the drug under the ordinary or customary conditions of handling, shipment, storage, and distribution.

18VAC110-20-500. Licensed emergency medical services (EMS) agencies. (Repealed.)

A. The pharmacy may prepare a kit for a licensed EMS agency provided:

1. The PIC of the hospital pharmacy shall be responsible for all prescription drugs and Schedule VI controlled devices contained in this kit. Except as authorized in 18VAC110-20-505, a pharmacist shall check each kit after filling and initial the filling record certifying the accuracy and integrity of the contents of the kit.

2. The kit is sealed, secured, and stored in such a manner that it will deter theft or loss of drugs and devices and aid in detection of theft or loss.

a. The hospital pharmacy shall have a method of sealing the kits such that once the seal is broken, it cannot be reasonably resealed without the breach being detected.

b. If a seal is used, it shall have a unique numeric or alphanumeric identifier to preclude replication or resealing. The pharmacy shall maintain a record of the seal identifiers when placed on a kit and maintain the record for a period of one year.

c. In lieu of a seal, a kit with a built-in mechanism preventing resealing or relocking once opened except by the provider pharmacy may be used.

3. Drugs and devices may be administered by an EMS provider upon an oral or written order or standing protocol of an authorized medical practitioner in accordance with § 54.1-3408 of the Code of Virginia. Oral orders shall be reduced to writing by the EMS provider and shall be signed by a medical practitioner. Written standing protocols shall be signed by the operational medical director for the EMS agency. A current copy of the signed standing protocol shall be maintained by the pharmacy participating in the kit exchange. The EMS provider shall make a record of all drugs and devices administered to a patient.

4. When the drug kit has been opened, the kit shall be returned to the pharmacy and exchanged for an unopened kit. The record of the drugs administered shall accompany the opened kit when exchanged. An accurate record shall be maintained by the pharmacy on the exchange of the drug kit for a period of one year. A pharmacist, pharmacy technician, or nurse shall reconcile the Schedule II, III, IV, or V drugs in the kit at the time the opened kit is returned. A record of the reconciliation, to include any noted discrepancies, shall be maintained by the pharmacy for a period of two years from the time of exchange. The theft or any other unusual loss of any Schedule II, III, IV, or V controlled substance shall be reported in accordance with § 54.1-3404 of the Code of Virginia.

5. Accurate records of the following shall be maintained by the pharmacy on the exchange of the drug kit for a period of one year:

a. The record of filling and verifying the kit to include the drug contents of the kit, the initials of the pharmacist verifying the contents, the date of verification, a record of an identifier if a seal is used, and the assigned expiration date for the kit, which shall be no later than the expiration date associated with the first drug or device scheduled to expire.

b. The record of the exchange of the kit to include the date of exchange and the name of EMS agency and EMS provider receiving the kit.

6. Destruction of partially used Schedules II, III, IV, and V drugs shall be accomplished by two persons, one of whom shall be the EMS provider and the other shall be a pharmacist, nurse, prescriber, pharmacy technician, or a second EMS provider. Documentation shall be maintained in the pharmacy for a period of two years from the date of destruction.

7. The record of the drugs and devices administered shall be maintained as a part of the pharmacy records pursuant to state and federal regulations for a period of not less than two years.

8. Intravenous and irrigation solutions provided by a hospital pharmacy to an emergency medical services agency may be stored separately outside the kit.

9. Any drug or device showing evidence of damage or tampering shall be immediately removed from the kit and replaced.

10. In lieu of exchange by the hospital pharmacy, the PIC of the hospital pharmacy may authorize the exchange of the kit by the emergency department. Exchange of the kit in the emergency department shall only be performed by a pharmacist, nurse, or prescriber if the kit contents include Schedule II, III, IV, or V drugs.

B. A licensed EMS agency may obtain a controlled substances registration pursuant to § 54.1-3423 D of the Code of Virginia for the purpose of performing a one-to-one exchange of Schedule VI drugs or devices.

1. The controlled substances registration may be issued to a single agency or to multiple agencies within a single jurisdiction.

2. The controlled substances registration issued solely for this intended purpose does not authorize the storage of drugs within the agency facility.

3. Pursuant to § 54.1-3434.02 of the Code of Virginia, the EMS provider may directly obtain Schedule VI drugs and devices from an automated drug dispensing device.

4. If such drugs or devices are obtained from a nurse, pharmacist, or prescriber, it shall be in accordance with the procedures established by the pharmacist-in-charge, which shall include a requirement to record the date of exchange, name of licensed person providing drug or device, name of the EMS agency and provider receiving the drug or device, and assigned expiration date. Such record shall be maintained by the pharmacy for one year from the date of exchange.

5. If an EMS agency is performing a one-to-one exchange of Schedule VI drugs or devices, Schedule II, III, IV, or V drugs shall remain in a separate, sealed container and shall only be exchanged in accordance with provisions of subsection A of this section.

18VAC110-20-505. Use of radio-frequency identification.

A. A hospital pharmacy may use radio-frequency identification (RFID) to verify the accuracy of drugs placed into a kit for licensed emergency medical services pursuant to 18VAC110-20-500 18VAC110-20-591 or other kits used as floor stock throughout the hospital under the following conditions:

1. A pharmacist shall be responsible for performing and verifying the accuracy of the following tasks:

a. The addition, modification, or deletion of drug information into the RFID database for assignment of a an RFID tag to an individual drug; and

b. The development of the contents of the kit in the RFID database and the associated drug-specific RFID tags.

2. A pharmacy technician may place the RFID tag on the drugs, and a pharmacist shall verify that all drugs have been accurately tagged prior to storing the drugs in the pharmacy's inventory.

3. A pharmacy technician may remove RFID-tagged drugs from the pharmacy's inventory whose RFID tags have been previously verified for accuracy by a pharmacist and place the drugs into the kit's container. A pharmacy technician may then place the container into the pharmacy's device that reads the RFID tags to verify if the correct drugs have been placed into the container as compared to the list of the kit's contents in the RFID database.

4. A pharmacist shall perform a daily random check for verification of the accuracy of 5.0% of all kits prepared that day utilizing the RFID technology. A manual or electronic record from which information can be readily retrieved, shall be maintained that includes:

a. The date of verification;

b. A description of all discrepancies identified, if any; and

c. The initials of pharmacist, verifying the accuracy of the process.

5. Pharmacies engaged in RFID tagging of drugs shall be exempt from the requirements in subsection C of 18VAC110-20-490, subsection A of 18VAC110-20-460, and subsection A of 18VAC110-20-355 A, 18VAC110-20-460 A, and 18VAC110-20-490 C.

6. All records required by this subsection shall be maintained for a period of one year from the date of verification by the pharmacist.

B. A registered EMS agency headquarters, regional EMS council, or designated location of the EMS agency or regional EMS council may use RFID to verify the accuracy of drugs placed into a kit for emergency medical services under the following conditions:

1. An EMS supervising practitioner or responsible party shall be responsible for performing and verifying the accuracy of the following tasks:

a. The addition, modification, or deletion of drug information into the RFID database for assignment of an RFID tag to an individual drug; and

b. The development of the contents of the kit in the RFID database and the associated drug-specific RFID tags.

2. A person authorized to administer drugs or a pharmacy technician may place the RFID tag on the drugs, and the EMS responsible party or designee authorized to administer drugs shall verify that all drugs have been accurately tagged prior to storing the drugs in the pharmacy's inventory.

3. A person authorized to administer drugs or a pharmacy technician may remove RFID-tagged drugs from the EMS inventory whose RFID tags have been previously verified for accuracy by the EMS responsible party or designee authorized to administer drugs and place the drugs into the kit's container. A person authorized to administer drugs may then place the container into the device that reads the RFID tags to verify if the correct drugs have been placed into the container as compared to the list of the kit's contents in the RFID database.

4. An EMS responsible party or designee authorized to administer drugs shall perform a weekly random check for verification of the accuracy of 5.0% of all kits prepared that week utilizing RFID technology. A manual or electronic record from which information can be readily retrieved shall be maintained that includes:

a. The date of verification;

b. A description of all discrepancies identified, if any; and

c. The initials of the EMS responsible party or designee authorized to administer drugs verifying the accuracy of the process.

5. All records required by this subsection shall be maintained for a period of one year from the date of verification by the EMS responsible party or designee authorized to administer drugs.

18VAC110-20-591. Allowances for emergency medical services agencies to obtain drugs.

A. This section contains specific provisions by which an EMS agency may obtain drugs for administration.

B. Unless prohibited by federal law, a pharmacy may prepare a kit for an EMS agency, provided:

1. The PIC of the pharmacy shall be responsible for all prescription drugs contained in this kit. Except as authorized in 18VAC110-20-505, a pharmacist shall (i) check each kit after filling and (ii) initial the filling record certifying the accuracy and integrity of the contents of the kit.

2. The kit containing drugs in Schedules II through V is sealed, secured, and stored in such a manner that will deter theft or loss of drugs and aid in detection of theft or loss. Kits containing only drugs in Schedule VI are not required to be sealed but must be secured in a manner to deter theft or loss.

a. The pharmacy shall have a method of sealing the kits such that once the seal is broken, it cannot be reasonably resealed without the breach being detected.

b. If a seal is used, it shall have a unique numeric or alphanumeric identifier to preclude replication or resealing. The pharmacy shall maintain a record of the seal identifiers when placed on a kit and maintain the record for a period of one year.

c. In lieu of a seal, a kit with a built-in mechanism preventing resealing or relocking once opened except by the provider pharmacy may be used.

3. A current copy of the signed standing protocol shall be maintained by the pharmacy participating in the kit exchange. The EMS provider shall make a record of all drugs administered to a patient.

4. When the drug kit has been opened, the kit shall be returned to the pharmacy and exchanged for an unopened kit. The record of the drugs administered shall accompany the opened kit when exchanged. An accurate record shall be maintained by the pharmacy on the exchange of the drug kit for a period of one year. A pharmacist, pharmacy technician, or nurse shall reconcile the Schedule II, III, IV, or V drugs in the kit at the time the opened kit is returned. A record of the reconciliation, to include any noted discrepancies, shall be maintained by the pharmacy for a period of two years from the time of exchange. The theft or any other unusual loss of any Schedule II, III, IV, or V controlled substance shall be reported in accordance with § 54.1-3404 of the Code of Virginia.

5. Accurate records of the following shall be maintained by the pharmacy on the exchange of the drug kit for a period of one year:

a. The record of filling and verifying the kit, to include the drug contents of the kit, the initials of the pharmacist verifying the contents, the date of verification, a record of an identifier if a seal is used, and the assigned expiration date for the kit, which shall be no later than the expiration date associated with the first drug scheduled to expire.

b. The record of the exchange of the kit, to include the date of exchange and the name of EMS agency and EMS provider receiving the kit.

6. Destruction of partially used Schedules II, III, IV, and V drugs shall be accomplished by two persons, one of whom shall be the EMS provider and the other shall be a pharmacist, nurse, prescriber, pharmacy technician, or a second EMS provider. Documentation shall be maintained in the pharmacy for a period of two years from the date of destruction.

7. The record of the drugs administered shall be maintained as a part of the pharmacy records pursuant to state and federal regulations for a period of not less than two years.

8. Intravenous and irrigation solutions provided by a pharmacy to an emergency medical services agency may be stored separately outside the kit.

9. Any drug showing evidence of damage or tampering shall be immediately removed from the kit and replaced.

10. In lieu of exchange by a hospital pharmacy, the PIC of the hospital pharmacy may authorize the exchange of the kit by the emergency department. Exchange of the kit in the emergency department shall only be performed by a pharmacist, nurse, prescriber, or pharmacy technician if the kit contents include Schedule II, III, IV, or V drugs.

11. Drug kits shall be secured on the EMS vehicle or other EMS vehicle at all times, unless the vehicle is incapable of maintaining appropriate drug storage temperature or is out of service. The EMS agency is not required to obtain a controlled substances registration pursuant to § 54.1-3423 D of the Code of Virginia to participate in a pharmacy kit exchange in accordance with this section unless the EMS agency needs to temporarily store a secured drug kit within the EMS building when a vehicle is incapable of maintaining appropriate drug storage temperature or is out of service and the EMS agency does not otherwise serve as a designated location of a current, active controlled substances registration. An alarm system consistent with requirements in 18VAC110-20-710 is not required under these conditions.

C. An EMS agency or regional EMS council that has been issued a controlled substances registration pursuant to 18VAC110-20-690 G and a registration from DEA in accordance with federal law may receive drugs in Schedules II through VI and deliver or transfer the drugs to any designated location of the registered EMS agency headquarters or regional EMS council. Delivery of the drugs shall not constitute wholesale distribution.

D. For sites that are not designated locations of the entity providing the drug, nothing shall preclude a hospital, EMS agency, or regional EMS council from transferring or distributing drugs in Schedule VI to another EMS agency, regional EMS council, or a designated location of either entity during a shortage of drugs or in an emergency.

E. A hospital, EMS agency, regional EMS council, and designated locations may deliver drugs in Schedules II through V to each other consistent with federal law in the event of shortages of such drugs, a public health emergency, or a mass casualty event. All entities transferring, delivering, and receiving drugs shall comply with recordkeeping requirements listed in 18VAC110-20-721.

F. In compliance with federal law, a hospital pharmacy may provide drugs to a hospital-owned EMS agency operating as an extension of the hospital pharmacy's DEA registration.

G. If an EMS agency that is not hospital owned has obtained a controlled substances registration and a DEA registration in accordance with federal law, a pharmacy may provide that EMS agency drugs for restocking an EMS vehicle or other EMS vehicle, provided all of the following criteria are met:

1. The registered or designated location of the agency operating the EMS vehicle or other EMS vehicle maintains the record of receipt of drugs in accordance with state and federal law.

2. The pharmacy maintains a record of the delivery to the EMS agency in accordance with state and federal law.

3. If the EMS vehicle or other EMS vehicle is primarily situated at a designated location of an EMS agency, the designated location notifies the registered location of the agency within 72 hours of the EMS vehicle or other EMS vehicle receiving drugs in Schedules II through V.

4. Pursuant to § 54.1-3434.02 of the Code of Virginia, the EMS provider may directly obtain Schedule VI drugs from an automated drug dispensing device.

5. If such drugs are obtained from a nurse, pharmacist, or prescriber, it shall be in accordance with the procedures established by the pharmacist-in-charge, which shall include a requirement to record the date of exchange, name of licensed person providing the drug, name of the EMS agency and provider receiving the drug, and assigned expiration date. Such record shall be maintained by the pharmacy for one year from the date of exchange.

6. If an EMS agency is performing a one-to-one exchange of Schedule VI drugs, such Schedule VI drugs shall remain in a separate container.

H. Schedule VI drugs stored on an EMS vehicle or other EMS vehicle are not required to be stored in a sealed kit, but must be stored in a manner to deter theft or loss. Drugs in Schedules II through V stored on a ground EMS vehicle, other EMS vehicle, or EMS vehicle that is a licensed fixed-wing aircraft shall be stored in a sealed, secured kit or device within a locked cabinet that is accessible from the patient compartment of the vehicle. Drugs in Schedules II through V stored on an EMS vehicle that is a licensed rotary aircraft shall be stored in a sealed, secured kit or device to deter theft or loss.

1. The method of sealing the kits shall ensure that once the seal is broken, it cannot be reasonably resealed without the breach being detected.

2. If a seal is used, it shall have a unique numeric or alphanumeric identifier to preclude replication or resealing. The EMS registered agency headquarters, regional EMS council, or designated location sealing and resealing the kit shall maintain a record of the seal identifiers when placed on a kit and maintain the record for a period of one year.

3. In lieu of a seal, a kit with a built-in mechanism preventing resealing or relocking once opened except by EMS personnel may be used.

I. Registered EMS agency headquarters, regional EMS councils, and designated locations of the registered EMS agency headquarters or regional EMS councils shall implement a process to review expiration dates no less often than every three months to ensure drugs are not administered beyond the expiration date.

J. Registered EMS agency headquarters, regional EMS councils, and designated locations of the registered EMS agency headquarters or regional EMS councils shall perform drug inventories and report drug theft or unusual loss to the board in accordance with § 54.1-3404 of the Code of Virginia.

K. Registered EMS agency headquarters and regional EMS councils shall audit the security of the drug storage location and perform a random audit of Schedules II through V drugs and required recordkeeping for accuracy at least every six months at each designated location under the controlled substances registration. Documentation verifying the completion of the audit for each designated location shall be maintained at the registered EMS agency headquarters or regional EMS council for two years from the date performed.

18VAC110-20-690. Persons or entities authorized or required to obtain a controlled substances registration.

A. A person or entity that maintains or intends to maintain a supply of Schedules II through Schedule VI controlled substances, other than manufacturers' manufacturer samples, in accordance with provisions of the Drug Control Act (§ 54.1-3400 et seq. of the Code of Virginia) may apply for a controlled substances registration on forms approved by the board.

B. Persons or entities that may be registered by the board shall include hospitals without in-house pharmacies, nursing homes without in-house pharmacies that use automated drug dispensing systems, ambulatory surgery centers, outpatient clinics, alternate delivery sites, crisis stabilization units, persons authorized by the Department of Behavioral Health and Developmental Services to train individuals on the administration of naloxone and to dispense naloxone for opioid overdose reversal, and emergency medical services agencies, and regional EMS councils, provided such persons or entities are otherwise authorized by law and hold required licenses or appropriate credentials to administer the drugs for which the registration is being sought.

C. In determining whether to register an applicant, the board shall consider factors listed in subsections A and D of § 54.1-3423 of the Code of Virginia and compliance with applicable requirements of this chapter.

1. The proposed location shall be inspected by an authorized agent of the board prior to issuance of a controlled substances registration.

2. Controlled substances registration applications that indicate a requested inspection date or requests that are received after the application is filed shall be honored provided a 14-day notice is allowed prior to the requested inspection date.

3. Requested inspection dates that do not allow a 14-day notice to the board may be adjusted by the board to provide 14 days for the scheduling of the inspection.

4. Any person wishing to change an approved location of the drug stock, make structural changes to an existing approved drug storage location, or make changes to a previously approved security system shall file an application with the board and be inspected.

5. Drugs shall not be stocked within the proposed drug storage location or moved to a new location until approval is granted by the board.

D. The application shall be signed by a person who will act as a responsible party for the controlled substances. The responsible party may be a prescriber, nurse, pharmacist, pharmacy technician for alternate delivery sites, a person authorized by the Department of Behavioral Health and Developmental Services to train individuals on the administration of naloxone and to dispense naloxone for opioid overdose reversal, or other person approved by the board who is authorized to administer the controlled substances.

E. The board may require a person or entity to obtain a controlled substances registration upon a determination that Schedules II through VI controlled substances have been obtained and are being used as common stock by multiple practitioners and that one or more of the following factors exist:

1. A federal, state, or local government agency has reported that the person or entity has made large purchases of controlled substances in comparison with other persons or entities in the same classification or category.

2. The person or entity has experienced a diversion, theft, or other unusual loss of controlled substances which requires reporting pursuant to § 54.1-3404 of the Drug Control Act.

3. The person or entity has failed to comply with recordkeeping requirements for controlled substances.

4. The person or entity or any other person with access to the common stock has violated any provision of federal, state, or local law or regulation relating to controlled substances.

F. The board may issue a controlled substance registration to an entity at which a patient is being treated by the use of instrumentation and diagnostic equipment through which images and medical records may be transmitted electronically for the purpose of establishing a bona fide practitioner-patient relationship and is being prescribed Schedules II through VI controlled substances when such prescribing is in compliance with federal requirements for the practice of telemedicine and the patient is not in the physical presence of a practitioner registered with the U.S. Drug Enforcement Administration provided:

1. There is a documented need for such registration, and issuance of the registration of the entity is consistent with the public interest;

2. The entity is under the general supervision of a licensed pharmacist or a practitioner of medicine, osteopathy, podiatry, dentistry, or veterinary medicine; and

3. The application is signed by a person who will act as the responsible party for the entity for the purpose of compliance with provisions of this subsection. The responsible party shall be a prescriber, nurse, pharmacist, or other person who is authorized by provisions of § 54.1-3408 of the Code of Virginia to administer controlled substances.

G. The board may issue a controlled substances registration to an EMS agency or regional EMS council to receive controlled substances in Schedules II through VI from a wholesale distributor, manufacturer, third-party logistics provider, warehouser, or pharmacy. The EMS agency or regional EMS council shall identify to the board any designated location to which the EMS agency or regional EMS council may deliver controlled substances. The EMS agency or regional EMS council shall also obtain a registration from DEA in accordance with federal law prior to delivery of Schedules II through V drugs. The EMS agency or regional EMS council shall identify on the controlled substances registration application the name and physical address of the designated locations and attest that each designated location of the EMS agency or regional EMS council complies with the storage and security requirements of 18VAC110-20-710. Any changes to the designated locations shall be submitted to the board in advance of delivering or ceasing to deliver controlled substances to that location and the designated locations must be approved sites under federal law.

H. An EMS agency receiving only Schedule VI drugs from a wholesale distributor, manufacturer, third-party logistics provider, warehouser, or pharmacy or temporarily storing a secured drug kit within the EMS building when the vehicle is incapable of maintaining appropriate drug storage temperature or is out of service shall obtain a controlled substance registration or operate as a designated location of a registered EMS agency headquarters.

18VAC110-20-710. Requirements for storage and security for controlled substances registrants.

A. Drugs shall be stored under conditions that meet USP-NF specifications or manufacturers' manufacturer's suggested storage for each drug.

B. Any drug that has exceeded the expiration date shall not be administered; it shall be separated from the stock used for administration and maintained in a separate, locked area until properly disposed.

C. If a controlled substances registrant wishes to dispose of unwanted or expired Schedules II through VI drugs, he the controlled substances registrant shall transfer the drugs to another person or entity authorized to possess and to provide for proper disposal of such drugs.

D. Drugs shall be maintained in a lockable cabinet, cart, device, or other area that shall be locked at all times when not in use. The keys or access code shall be restricted to the supervising practitioner and persons designated access in accordance with 18VAC110-20-700 C.

E. A registered EMS agency headquarters or regional EMS council may store controlled substances in an automated dispensing device that is located at a secured site at the registered location or designated location of the EMS agency or regional EMS council that is (i) installed and operated by the EMS agency or regional EMS council, (ii) not used to directly dispense controlled substances to an ultimate user, and (iii) is in compliance with the requirements of state law.

F. In a facility not staffed 24 hours a day, the drugs shall be stored in a fixed and secured room, cabinet, or area that has a security device for the detection of breaking that meets the following conditions:

1. The device shall be a sound, microwave, photoelectric, ultrasonic, or any other generally accepted and suitable device.

2. The installation and device shall be based on accepted alarm industry standards.

3. The device shall be maintained in operating order, have an auxiliary source of power, be monitored in accordance with accepted industry standards, be maintained in operating order; and shall be capable of sending an alarm signal to the monitoring entity if breached and the communication line is not operational.

4. The device shall fully protect all areas where prescription drugs are stored and shall be capable of detecting breaking by any means when activated.

5. Access to the alarm system shall be restricted to only designated and necessary persons, and the system shall be activated whenever the drug storage areas are closed for business.

6. An alarm system is not required for researchers,; animal control officers,; humane societies,; alternate delivery sites as provided in 18VAC110-20-275, emergency medical services agencies; registered EMS agencies or regional EMS councils, or designated locations of registered EMS agency headquarters or regional EMS councils stocking only intravenous fluids with no added drug, Schedule VI drugs or temporarily securing a secured drug kit that may contain Schedules II through VI drugs when the EMS vehicle or other EMS vehicle cannot maintain appropriate drug storage temperature or is out of service; persons authorized by the Department of Behavioral Health and Developmental Services to train individuals on the administration of naloxone and to dispense naloxone for opioid overdose reversal,; and teaching institutions possessing only Schedule VI drugs.

G. A registered EMS agency headquarters or regional EMS council may store controlled substances at any of the following secured locations:

1. A registered location of the EMS agency or regional EMS council;

2. A designated location of the EMS agency or regional EMS council of which the board has been notified and DEA has granted approval if stocking drugs in Schedules II through V;

3. In an EMS vehicle or other EMS vehicle situated at a registered location or designated location of the EMS agency or regional EMS council or other location where an EMS agency approves an EMS vehicle to be stored; or

4. In an EMS vehicle or other EMS vehicle used by the EMS agency that is traveling from or returning to a registered location or designated location of the EMS agency or EMS council or other location where an EMS agency approves an EMS vehicle to be stored in the course of responding to an emergency or otherwise actively in use by the EMS agency.

H. Drugs secured in an EMS agency, regional EMS council, EMS vehicle, or other EMS vehicle shall be stored at an appropriate temperature pursuant to manufacturer's directions at all times. If the EMS vehicle or other EMS vehicle cannot maintain appropriate temperature or is out of service, the drug kit may be temporarily maintained within the building of the EMS agency. The drug kit shall be stored in compliance with this section.

18VAC110-20-720. Requirements for recordkeeping.

The person named as the responsible party on the controlled substances registration shall be responsible for recordkeeping for Schedule Schedules II through VI drugs in accordance with provisions of § 54.1-3404 of the Code of Virginia to include the reporting of any drug theft or unusual loss and the following:

1. Inventories and administration records of Schedule II drugs shall be maintained separately from all other records and shall be kept in chronological order by date of administration.

2. All Except as provided in subdivision 9 of this section, all records shall be maintained at the same location as listed on the controlled substances registration or, if maintained in an off-site database, retrieved and made available for inspection or audit within 48 hours of a request by the board or an authorized agent.

3. In the event that an inventory is taken as the result of a theft of drugs, the inventory shall be used as the opening inventory within the current biennial period. Such an inventory does not preclude the taking of the required inventory on the required biennial inventory date. All inventories required by § 54.1-3404 of the Code of Virginia shall be signed and dated by the person taking the inventory and shall indicate whether the inventory was taken prior to the opening or after the close of business on that date. An entity which that is open 24 hours a day shall clearly document whether the receipt or distribution of drugs on the inventory date occurred before or after the inventory was taken.

4. Any computerized system used to maintain records shall also provide retrieval via computer monitor display or printout of the history for drugs administered during the past two years. It shall also have the capacity of producing a printout of any data which that the registrant is responsible for maintaining under the Drug Control Act (§ 54.1-3400 et seq. of the Code of Virginia).

5. The Department of Forensic Science may exclude from any inventory quantities of controlled substances used to conduct chemical analyses and controlled substances received for analyses as evidentiary material as provided in § 54.1-3404 G of the Code of Virginia.

6. Documents that describe the conditions and extent of the responsible party's authorization to dispense controlled substances for each EMS provider employed by or practicing at an EMS agency holding a controlled substances registration. Such documents shall be maintained in a readily retrievable manner and be available for inspection and copying by authorized agents of the board. Examples of such documentation include protocols, practice guidelines, or practice agreements.

7. Records of all controlled substances that are received, administered, or otherwise disposed of, records of deliveries of controlled substances between all locations of an EMS agency or regional EMS council pursuant to the controlled substance registration, and record of the standing or verbal orders issued or adopted.

8. Documentation verifying the completion of audit for each designated location pursuant to 18VAC110-20-591 K.

9. Records required to be maintained by an EMS agency or regional EMS council shall be maintained, whether electronically or otherwise, pursuant to subdivision 2 of this section or at each registered location, designated location of the EMS agency, or regional EMS council where the controlled substances involved are received, administered, or otherwise disposed of for two years from the date of execution of the record.

18VAC110-20-721. Additional recordkeeping requirements for EMS agencies.

A. Each EMS agency holding a controlled substances registration or serving as a designated location of an EMS agency or regional EMS council, including a hospital-owned EMS agency operating under a hospital registration, responsible for administering a drug must maintain written standing protocols signed by the operational medical director for the EMS agency that authorize the administration. Oral orders authorizing the administration shall be reduced to writing by the EMS provider and shall be signed by a medical practitioner and maintained by the EMS entity responsible for administering the drug.

B. A record for each dose of drug in Schedules II through VI administered and destruction of partially administered drug in the course of providing emergency medical services must also be maintained. Destruction of partially used Schedules II, III, IV, and V drugs shall be accomplished by two persons, one of whom shall be the EMS provider and the other shall be a pharmacist, nurse, prescriber, pharmacy technician, or a second EMS provider. Except as indicated in 18VAC110-20-591 for emergency drug kits provided by a pharmacy, documentation shall be maintained in the EMS agency or the designated location of an EMS agency or regional EMS council for a period of two years from the date of destruction.

C. The following records shall be maintained for each acquisition of a drug in Schedules II through VI from another registrant of the board or each distribution of a drug in Schedules II through VI to another registrant of the board:

1. For each acquisition of a drug from another registrant:

a. Name of the drug;

b. Finished form of the drug (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter);

c. Number of units or volume of finished form in each commercial container (e.g., 100-tablet bottle or three-milliliter vial);

d. Number of commercial containers acquired;

e. Date of the acquisition;

f. Name, address, and registration number of the person from whom the substance was acquired; and

g. Name and title of the person acquiring the drug.

2. For each distribution of drug in Schedules II through VI to another registrant:

a. Name of the drug;

b. Finished form of the drug (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter);

c. Number of units or volume of finished form in each commercial container (e.g., 100-tablet bottle or three-milliliter vial);

d. Number of commercial containers distributed;

e. Date of the distribution;

f. Name, address, and registration number of the person to whom the substance was distributed; and

g. Name and title of the person in receipt of the distributed drugs.

3. For each delivery of drug in Schedules II through VI between a designated location and a registered location:

a. Name of the drug;

b. Finished form of the drug (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter);

c. Number of units or volume of finished form in each commercial container (e.g., 100-tablet bottle or three-milliliter vial);

d. Number of units or volume of finished form in each commercial container and number of commercial containers delivered (e.g., 100-tablet bottle or three-milliliter vial);

e. Date of the delivery;

f. Name and address of the designated location to which the substance was delivered; and

g. Name and title of the person in receipt of the controlled substances.

4. For destruction of a drug in Schedules II through VI, unless otherwise authorized under federal law, expired or unwanted drugs shall be transferred to another person or entity authorized to possess or provide for proper disposal of such drugs.

D. A designated location of an EMS agency that receives drugs in Schedules II through V must notify the EMS agency's registered location within 72 hours of receipt of the drugs in the following circumstances:

1. An EMS vehicle or other EMS vehicle primarily situated at a designated location of the EMS agency acquires drug from a hospital while restocking following a response; or

2. The designated location of the EMS agency receives drugs from another designated location of the same agency.

E. To the extent permitted by federal law, registered EMS agency headquarters, regional EMS councils, or designated locations of the EMS agency or regional EMS council in which the repackaging or prepackaging of over-the-counter drugs is performed shall maintain adequate control records for a period of one year or until the expiration of the drugs, whichever is greater.

1. The records shall show the name of the drugs used; strength, if any; date repackaged; quantity prepared; initials of the pharmacist, EMS responsible party, or designee authorized to administer drugs verifying the process; the assigned lot or control number; the manufacturer or distributor name and lot or control number; and an expiration date.

2. Any subsequently repackaged units shall show the name of the drug; strength, if any; the assigned lot or control number or the manufacturer or distributor name and lot or control number; and an appropriate expiration date determined by the pharmacist, EMS responsible party, or designee authorized to administer drugs in accordance with USP guidelines.

3. Repackaging of drugs shall be performed in compliance with USP-NF standards.